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A Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics and Clinical Activity of GSK2816126 in Subjects With Relapsed/Refractory Diffuse Large B Cell Lymphoma, Transformed Follicular Lymphoma, Other Non-Hodgkin's Lymphomas, Solid Tumors and Multiple Myeloma

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ClinicalTrials.gov Identifier: NCT02082977
Recruitment Status : Terminated (The maximal dose and schedule attained with GSK2816126 has shown insufficient evidence of clinical activity, and does not justify further clinical investigation)
First Posted : March 11, 2014
Results First Posted : June 28, 2019
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cancer
Neoplasms
Intervention Drug: GSK2816126
Enrollment 41
Recruitment Details This was a 2-part study in participants with relapsed/refractory diffuse large B cell lymphoma, transformed follicular lymphoma, other Non-Hodgkin's lymphomas, solid tumors and multiple myeloma (MM). In Part 1 dose escalation, participants received 50 to 3000 milligrams (mg) of GSK2816126, and Part 2 was dose expansion.
Pre-assignment Details This study was terminated prior to the completion of Part 1 due to an unfavorable benefit risk profile. Part 2 was not conducted. Approximately 42 participants screened, of which 41 were treated in Part 1 including 20 participants with lymphoma and 21 with solid tumors, of these 22 completed, 5 died and 14 participants were withdrawn.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly Part 2: All Participants
Hide Arm/Group Description Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D).
Period Title: Part 1 (Up to 3.2 Years)
Started 2 1 1 1 3 4 10 12 7 0
Completed 1 1 1 1 2 1 4 7 4 0
Not Completed 1 0 0 0 1 3 6 5 3 0
Reason Not Completed
Death             1             0             0             0             0             1             2             0             1             0
Study closed/terminated             0             0             0             0             0             0             0             2             0             0
Lost to Follow-up             0             0             0             0             0             1             0             0             0             0
Physician Decision             0             0             0             0             1             1             4             1             2             0
Withdrawal by Subject             0             0             0             0             0             0             0             2             0             0
Period Title: Part 2 (Up to 3.2 Years)
Started 0 0 0 0 0 0 0 0 0 0
Completed 0 0 0 0 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0 0 0 0 0
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly Part 2: All Participants Total
Hide Arm/Group Description Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Participants with Germinal Center B-cell-like Diffuse Large B-cell Lymphoma (GCB-DLBCL)-mutant and wild type, Transformed Follicular Lymphoma (TFL)-mutant and wild type as well as with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive recommended Phase II dose (RP2D) . Total of all reporting groups
Overall Number of Baseline Participants 2 1 1 1 3 4 10 12 7 0 41
Hide Baseline Analysis Population Description
Data was not collected in Part 2 of the study as no participant was enrolled in Part 2.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants 0 participants 41 participants
44.0  (12.73) 54.0 [1]   (NA) 56.0 [1]   (NA) 69.0 [1]   (NA) 53.3  (4.04) 49.5  (17.18) 61.1  (14.10) 61.9  (14.65) 58.4  (14.30) 58.2  (13.81)
[1]
NA indicates data was not available as standard deviation could not be calculated for single participant.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants 0 participants 41 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
  66.7%
1
  25.0%
2
  20.0%
7
  58.3%
4
  57.1%
16
  39.0%
Male
2
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
1
  33.3%
3
  75.0%
8
  80.0%
5
  41.7%
3
  42.9%
25
  61.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants 0 participants 41 participants
African American/African Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   2.4%
Asian-Central/South Asian Heritage
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   2.4%
White - White/Caucasian/European Heritage
2
 100.0%
1
 100.0%
1
 100.0%
1
 100.0%
3
 100.0%
4
 100.0%
8
  80.0%
12
 100.0%
5
  71.4%
37
  90.2%
Mixed white race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  14.3%
1
   2.4%
Unknown
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  10.0%
0
   0.0%
0
   0.0%
1
   2.4%
1.Primary Outcome
Title Part 1: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (Non-SAEs)
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. The analysis was performed on All Subjects Population which included all participants who received at least one dose of study treatment.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
Any Non-SAE 2 1 1 1 3 4 10 12 7
Any SAE 1 0 0 0 1 2 1 5 3
2.Primary Outcome
Title Part 1: Number of Participants With Dose Limiting Toxicities (DLT)
Hide Description An event was considered a DLT if it occurred within first 4 weeks (28 days) of treatment, and met the criteria's for hematologic , non-hematologic, infusion reactions and other toxicities, unless it can be clearly established that the event is unrelated to treatment.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 2
3.Primary Outcome
Title Part 1: Number of Participants Withdrawn Due to AEs
Hide Description A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. Participants were monitored from start of the study till the development of toxicity. The data for number of participants withdrawn due to AEs have been presented.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0
4.Primary Outcome
Title Part 1: Number of Participants With Dose Interruptions
Hide Description The number of participants who had any dose interruptions have been presented.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 1 1 3 5
5.Primary Outcome
Title Part 1: Number of Participants With Dose Reductions
Hide Description The number of participants who had any dose reductions have been presented.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 1 0 0 0 1
6.Primary Outcome
Title Part 1: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Hide Description Blood samples were collected for evaluation of clinical chemistry parameters including direct bilirubin, chloride, lactate dehydrogenase (LDH), total protein, urea/blood urea nitrogen (BUN) and uric acid. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are not gradable by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
Direct Bilirubin; To Low; n=1,1,1,1,3,4,8,12,7 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 8 participants 12 participants 7 participants
0 0 0 0 0 0 0 0 0
Direct Bilirubin; To Normal; n=1,1,1,1,3,4,8,12,7 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 8 participants 12 participants 7 participants
1 1 1 0 3 4 8 9 7
Direct Bilirubin; To High; n=1,1,1,1,3,4,8,12,7 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 8 participants 12 participants 7 participants
0 0 0 1 0 0 0 3 0
Chloride; To Low;n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 0 0 0 0 0 2 3 1
Chloride; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 1 1 1 3 4 6 8 6
Chloride; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 2 1 0
LDH; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 1 0 1
LDH; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 1 1 3 4 8 9 5
LDH; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 0 0 0 0 1 3 2
Total Protein; To Low n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 1 1 1 2 0 3 3 2
Total Protein; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 0 0 0 1 4 8 9 5
Total Protein; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 0 1 0
Urea/BUN; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 0 1 1
Urea/BUN; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 0 1 1 1 4 7 5 4
Urea/BUN; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 1 0 0 2 0 3 6 2
Uric acid; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 1 0 0 0 0 1 1 1
Uric acid; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 0 0 0 3 3 7 8 4
Uric acid; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 1 1 0 1 2 4 2
7.Primary Outcome
Title Part 1: Number of Participants With Worst Case Change From Baseline in Hematology Parameters
Hide Description Blood samples were collected for the analysis of hematology parameters including basophils, eosinophils, hematocrit, mean corpuscular hemoglobin concentration (MCHC), mean corpuscular hemoglobin (MCH), mean corpuscular volume (MCV), monocytes, segmented (seg) neutrophils, red blood cell (RBC) count and reticulocytes. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. The summaries of worst case change from Baseline with respect to normal range have been presented for only those laboratory tests that are not gradable by CTCAE version 4.0. The number of participants with decreases to low, changes to normal or no changes from Baseline, and increases to high values have been presented. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Baseline and up to 3.2 years
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All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
Basophils; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 0 0 0 1 1 1 3 2
Basophils; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 1 1 1 2 3 9 9 5
Basophils; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 0 0 0
Eosinophils; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 3 1 1 2 0
Eosinophils; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 1 1 0 3 7 10 7
Eosinophils; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 2 0 0
Hematocrit; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 1 0 2 2 4
Hematocrit; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 1 1 2 4 8 10 3
Hematocrit; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 1 0 0 0 0
MCHC; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 1 0 0 2 7 5 2
MCHC; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 0 1 2 2 2 7 5
MCHC; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 1 0 2 0 0
MCH; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 1 0 0 0 0
MCH; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 1 0 2 4 7 11 7
MCH; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 1 0 0 3 1 0
MCV; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 1 0 0 0 0
MCV; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 1 1 1 2 3 9 11 7
MCV; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 0 0 0 0 1 1 1 0
Monocytes; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 1 0 0 1 1
Monocytes; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 1 1 2 4 5 9 5
Monocytes; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 5 2 1
Seg Neutrophils; To Low; n= 0,0,0,0,0,0,0,0,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0
Seg Neutrophils; To Normal; n= 0,0,0,0,0,0,0,0,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
1
Seg Neutrophils; To High; n= n= 0,0,0,0,0,0,0,0,1 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants
0
RBC count; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 0 0 0 0 0 4 4 3
RBC count; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1 1 1 1 3 4 6 8 4
RBC count; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 0 0 0
Reticulocytes; ; To Low; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 1 1 1 5 2 3
Reticulocytes; To Normal; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
2 1 1 0 2 3 5 10 4
Reticulocytes; To High; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0 0 0 0 0 0 0 1 1
8.Primary Outcome
Title Part 1:Number of Participants With Abnormal Values for Vital Signs
Hide Description Vital sign measurements includes systolic blood pressure (SBP), diastolic blood pressure (DBP), body temperature and heart rate. Vital signs were measured after resting for at least 5 minutes in a semi-supine position. The number of participants with abnormal findings for vital signs have been presented.
Time Frame Up to 3.2 years
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All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
SBP 1 0 0 0 0 0 3 3 0
DBP 0 0 0 0 1 1 2 5 0
Heart rate 1 0 0 0 0 0 1 2 2
Body temperature 0 0 0 0 0 0 0 0 0
9.Primary Outcome
Title Part 1: Number of Participants With Abnormal Findings for Electrocardiogram (ECG) Parameters
Hide Description Single measurements of 12-lead ECGs were obtained a semi-recumbent or semi-supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and corrected QT (QTc) intervals. The number of participants with abnormal, abnormal-not clinically significant (NCS), and abnormal-clinically significant (CS) worst case Post Baseline findings have been presented.
Time Frame Up to 3.2 years
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All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
Abnormal; NCS 0 0 0 0 0 1 3 6 2
Abnormal; CS 0 1 0 0 1 1 0 1 0
Abnormal 2 0 0 1 1 2 5 5 4
10.Primary Outcome
Title Part 2: Percentage of Participants Achieving Overall Response Rate
Hide Description Overall response rate is defined as percentage of participants achieving complete response and partial response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
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Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) to Last Time of Quantifiable Concentration (AUC [0-t]) Following Single and Repeat Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-t) following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. The analysis was performed on Pharmacokinetic Population which included all participants in the All Subject population for whom a blood sample for pharmacokinetics was analyzed and at least 1 non-missing values was obtained. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
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Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*microgram per milliliter
Day 1; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1.20
(62%)
27.20 [1] 
(NA%)
27.70 [1] 
(NA%)
11.80 [1] 
(NA%)
24.18
(10%)
85.72
(91%)
45.93
(23%)
92.41
(26%)
93.96
(48%)
Day 15; n=1,1,1,1,3,4,9,11,4 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 9 participants 11 participants 4 participants
3.20 [1] 
(NA%)
5.70 [1] 
(NA%)
7.10 [1] 
(NA%)
13.10 [1] 
(NA%)
25.82
(30%)
53.41
(14%)
68.72
(75%)
105.29
(29%)
158.44
(35%)
[1]
NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
12.Secondary Outcome
Title Part 1: Area Under the Concentration-time Curve From Time Zero (Pre-dose) Extrapolated to Infinite Time (AUC [0-infinity]) Following Single Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-infinity) following single (Day 1) dose administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants.
Time Frame Pre-dose, 0.5, 1, 2, 12, 18 , 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 (Each cycle was of 28 days)
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Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 0 0 1 3 1 10 10 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*Microgram per milliliter
1.33
(82%)
13.20 [1] 
(NA%)
26.41
(12%)
60.90 [1] 
(NA%)
51.15
(23%)
102.48
(28%)
103.17
(48%)
[1]
NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
13.Secondary Outcome
Title Part 1: Area Under the Concentration-time Curve Over the Dosing Interval (AUC [0-tau]) Following Repeat Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including AUC (0-tau) following repeat (Day 15) dose administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
Time Frame Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at specific time point were analyzed.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 1 1 1 1 3 4 9 11 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Hour*Microgram per milliliter
2.90 [1] 
(NA%)
5.70 [1] 
(NA%)
7.10 [1] 
(NA%)
12.30 [1] 
(NA%)
26.85
(25%)
53.66
(14%)
59.70
(25%)
111.32
(25%)
157.88
(36%)
[1]
NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
14.Secondary Outcome
Title Part 1: Trough (Pre-dose) Concentration at the End of Dosing Interval on the Specified Days (Ctau) Following Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including Ctau following specified days (Days 8 and 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available as data could not be calculated due to limited number of participants at specified data point. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose from start of infusion till end of infusion on Cycle 1 of Day 8; Pre-dose, 0.5, 1, 2, 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Only those participants with data available at specified time point were analyzed.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
Day 8; n=2,1,1,1,3,4,9,11,6 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 9 participants 11 participants 6 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
0.10
(0%)
0.14
(79%)
0.15
(38%)
0.33
(97%)
0.41
(147%)
Day 15; n=1,1,1,1,3,4,10,11,4 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 11 participants 4 participants
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
NA [1] 
(NA%)
0.10
(0%)
0.13
(59%)
0.16
(43%)
0.26
(56%)
0.54
(169%)
[1]
NA indicates data was not available due to limited number of participants to calculate the data.
15.Secondary Outcome
Title Part 1: Maximum Observed Plasma Concentration (Cmax) Following Single and Repeat Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including Cmax following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: Microgram per milliliter
Day 1; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
0.42
(52%)
1.10 [1] 
(NA%)
1.40 [1] 
(NA%)
4.00 [1] 
(NA%)
7.31
(16%)
10.91
(10%)
13.04
(27%)
22.26
(35%)
23.83
(21%)
Day 15; n=1,1,1,1,3,4,9,11,4 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 9 participants 11 participants 4 participants
0.50 [1] 
(NA%)
1.00 [1] 
(NA%)
1.50 [1] 
(NA%)
3.50 [1] 
(NA%)
7.46
(13%)
11.62
(27%)
14.21
(27%)
21.62
(27%)
30.48
(14%)
[1]
NA indicates data was not available since geometric coefficient of variation could not be calculated for single participant.
16.Secondary Outcome
Title Part 1: Time to Reach Cmax (Tmax) Following Single and Repeat Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including Tmax following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Tmax is the time to reach Cmax, determined directly from the concentration-time data. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Median (Full Range)
Unit of Measure: Hours
Day 1; n=2,1,1,1,3,4,10,12,7 Number Analyzed 2 participants 1 participants 1 participants 1 participants 3 participants 4 participants 10 participants 12 participants 7 participants
1.50
(1.0 to 2.0)
1.00
(1.0 to 1.0)
2.00
(2.0 to 2.0)
1.90
(1.9 to 1.9)
1.00
(0.5 to 1.9)
2.05
(1.1 to 72.0)
1.95
(1.0 to 2.9)
2.00
(0.8 to 2.8)
2.00
(0.5 to 3.3)
Day 15; n=1,1,1,1,3,4,9,11,4 Number Analyzed 1 participants 1 participants 1 participants 1 participants 3 participants 4 participants 9 participants 11 participants 4 participants
2.70
(2.7 to 2.7)
2.00
(2.0 to 2.0)
1.00
(1.0 to 1.0)
1.00
(1.0 to 1.0)
2.00
(1.9 to 2.0)
2.05
(2.0 to 2.1)
1.90
(0.5 to 2.7)
2.00
(1.0 to 3.0)
2.25
(2.0 to 3.0)
17.Secondary Outcome
Title Part 1: Apparent Terminal Phase Elimination Rate Constant (Lambda z) Following Single and Repeat Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including lambda z following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Median (Full Range)
Unit of Measure: Hours^-1
Day 1; n=2,0,0,1,3,1,10,10,7 Number Analyzed 2 participants 0 participants 0 participants 1 participants 3 participants 1 participants 10 participants 10 participants 7 participants
0.15
(0.1 to 0.2)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.1)
Day 15; n=1,1,0,1,2,4,9,11,4 Number Analyzed 1 participants 1 participants 0 participants 1 participants 2 participants 4 participants 9 participants 11 participants 4 participants
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.0)
0.00
(0.0 to 0.1)
0.00
(0.0 to 0.1)
0.00
(0.0 to 0.0)
18.Secondary Outcome
Title Part 1: Apparent Terminal Phase Half-life (T1/2) Following Single and Repeat Dose Administration of GSK2816126
Hide Description Blood samples were collected from participants for pharmacokinetic analysis including T1/2 following single (Day 1) and repeat dose (Day 15) administration of GSK2816126. Pharmacokinetic analysis of GSK2816126 in Part 1 was conducted by non-compartmental methods. Pharmacokinetic parameter derivation for some participants did not strictly conform to the prescribed acceptance criteria and hence data was not available for those participants. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Median (Full Range)
Unit of Measure: Hours
Day 1; n=2,0,0,1,3,1,10,10,7 Number Analyzed 2 participants 0 participants 0 participants 1 participants 3 participants 1 participants 10 participants 10 participants 7 participants
8.90
(4.3 to 13.5)
49.10
(49.1 to 49.1)
27.20
(19.4 to 35.2)
14.10
(14.1 to 14.1)
32.55
(23.0 to 39.0)
32.10
(25.6 to 48.8)
21.80
(8.5 to 45.3)
Day 15; n=1,1,0,1,2,4,9,11,4 Number Analyzed 1 participants 1 participants 0 participants 1 participants 2 participants 4 participants 9 participants 11 participants 4 participants
46.50
(46.5 to 46.5)
36.80
(36.8 to 36.8)
39.70
(39.7 to 39.7)
27.40
(25.7 to 29.1)
26.85
(23.0 to 33.8)
30.00
(12.2 to 65.7)
25.70
(8.2 to 38.3)
30.20
(15.1 to 40.3)
19.Secondary Outcome
Title Part 1: Accumulation Ratio Following Administration of GSK2816126
Hide Description Accumulation ratio was determined from the ratio of AUC (0-tau) on Cycle 1 Day 15/AUC (0-tau) on Cycle 1 Day 1 by dose cohort. Only those participants with data available at the specified data points were analyzed. To assess accumulation ratio for a dose level based on ANOVA method, it was required that at least 2 participants had derived PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For dose 50mg, 2 participants received treatment but there was one participant whose AUC(0- tau) on Cycle 1 Day 15 could not be derived due to discontinuation of treatment before Day 15. Hence, accumulation ratio could not be calculated for these 4 arms. Accumulation ratio of GSK2816126 was estimated by calculating the ratio of geometric least squares (GLS) means of the AUC between Day 15 and Day 1 for all dose levels and corresponding 90 percent (%) confidence interval (CI) for each ratio.
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. To assess accumulation ratio by ANOVA, it requires at least 2 participants to derive PK parameter AUC(0- tau) on both Cycle 1 Day 1 and Cycle 1 Day 15 which was not observed for dose 50mg, 100mg, 200mg and 400mg. Hence data could not be calculated for these 4 arms.
Arm/Group Title Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 3 4 9 11 4
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Ratio of AUC
1.090
(0.827 to 1.435)
0.625
(0.291 to 1.345)
1.288
(1.173 to 1.415)
1.224
(1.081 to 1.386)
1.801
(0.819 to 3.959)
20.Secondary Outcome
Title Part 1: Time Invariance Ratio Following Administration of GSK2816126
Hide Description Ratio of AUC(0-tau) on Day15/Day1 AUC(0-inf) was calculated to assess time invariance. Only those participants with data available at specified data points were analyzed. To assess time invariance based on ANOVA method, it is required that at least 2 participants in a dose level had AUC(0-inf) on Cycle1 Day1 and AUC(0-tau) on Cycle1 Day15. For dose 100mg, 200mg and 400mg, only 1 participant received treatment. For 50mg, 2 participants received treatment but there was one participant whose AUC(0-tau) on Cycle1 Day15 could not be derived due to discontinuation of treatment before Day15, so time invariance could not be calculated. For 1200mg, 4 participants received treatment, however, AUC(0-inf) derivation on Cycle1 Day1 for 3 out of 4 participants did not strictly conform to the prescribed acceptance criteria. Time invariance ratio of GSK2816126 was estimated by calculating ratio of GLS means of AUC between Day15 and Day1 for all dose levels and corresponding 90% CI for each ratio.
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
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Hide Analysis Population Description
Pharmacokinetic Population. To assess time invariance by ANOVA, it requires at least 2 participants to have AUC(0-inf) and AUC(0-tau) on Cycle1 Day15 which was not observed for dose 50mg, 100mg, 200mg, 400mg. For 1200mg, AUC(0-inf) on Cycle1 Day1 for 3 participants did not meet acceptance criteria. Data could not be calculated for these 5 arms.
Arm/Group Title Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 3 9 9 4
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: Ratio of AUC
1.016
(0.814 to 1.269)
1.157
(1.074 to 1.247)
1.091
(0.937 to 1.269)
1.606
(0.806 to 3.198)
21.Secondary Outcome
Title Part 1: Exposure Producing 50 Percent of the Maximum Effect (EC50) of GSK2816126 With Respect to Exposure Markers
Hide Description The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned to be based on Pharmacodynamic Population which consists of participants in the All Subjects population for whom a pharmacodynamics/biomarkers sample was obtained and analyzed. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.
Time Frame Up to 3.2 years
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Hide Analysis Population Description
Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
22.Secondary Outcome
Title Part 1: Maximum Effect (Emax) of GSK2816126 With Respect to Exposure Markers
Hide Description The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed as the pharmacodynamic response was not observed and therefore a relationship between pharmacokinetic and pharmacodynamic parameters could not be determined.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Analysis was not performed as pharmacodynamic response was not observed.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
23.Secondary Outcome
Title Part 1: Number of Participants With Overall Change in Tri-methylated Histone H3 Lysine 27 (H3K27me3) Ratios Compared to Baseline
Hide Description The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. Peripheral blood mononuclear cell [PBMCs], blood, skin or hair) were collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value.
Time Frame Baseline and up to 3.2 years
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Hide Analysis Population Description
Pharmacodynamic Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 3 4 10 12 7
Measure Type: Number
Unit of Measure: Participants
0 0 0 0 0 0 0 0 0
24.Secondary Outcome
Title Part 1: Percentage of Participants With Solid Tumors Achieving Best Overall Response Rate
Hide Description Overall response rate is defined as percentage of participants achieving complete response and partial response per RECIST version 1.1. Complete Response is the disappearance of all target/non-target lesions. Partial Response is at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The percentage of participants with solid tumors (including prostate) achieving best overall response rate have been presented. No participants with solid tumors were treated at doses below 800mg (i.e. 50mg, 100mg, 200mg, 400mg). Hence data could not be calculated for these 4 arms.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population.Only those participants with data available at specific time point were analyzed. No participants with solid tumors were treated at doses below 800mg (i.e. 50mg, 100mg, 200mg, 400mg). Hence data could not be calculated for these 4 arms.
Arm/Group Title Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 1 2 5 8 5
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 0 0
25.Secondary Outcome
Title Part 1: Percentage of Participants With Lymphoma Achieving Best Overall Response Rate
Hide Description Overall response rate is defined as percentage of participants achieving complete response and partial response per RECIST version 1.1. Complete Response is the disappearance of all target/non-target lesions. Partial Response is at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence. The percentage of participants with lymphoma achieving best overall response rate have been presented.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 2 1 1 1 2 2 5 4 2
Measure Type: Number
Unit of Measure: Percentage of participants
0 0 0 0 0 0 20 0 0
26.Secondary Outcome
Title Part 1: Concentration of GSK2816126 and Its Metabolites in Blood
Hide Description Blood samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.
Time Frame Pre-dose, 0.5, 1, 2, (12, 18 on Day 1 only), 24, and 96 hours post-dose from start of infusion; 0.5, 1, 2, 4, 6 hours from end of infusion on Cycle 1 of Day 1 and Day 15 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Samples were not collected due to early study termination.
Arm/Group Title Part 1: Participants With GCB-DLBCL Part 1: Participants With Solid Tumors
Hide Arm/Group Description:
At maximum tolerated or recommended phase II dose, participants with GCB-DLBCL were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
At maximum tolerated or recommended phase II dose, participants with solid tumors were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
27.Secondary Outcome
Title Part 1: Concentration of GSK2816126 and Its Metabolites in Bile
Hide Description Bile samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites via the Entero-Test. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Samples were not collected due to early study termination.
Arm/Group Title Part 1: Participants With GCB-DLBCL Part 1: Participants With Solid Tumors
Hide Arm/Group Description:
At maximum tolerated or recommended phase II dose, participants with GCB-DLBCL were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
At maximum tolerated or recommended phase II dose, participants with solid tumors were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Secondary Outcome
Title Part 1: Concentration of GSK2816126 and Its Metabolites in Urine
Hide Description Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.
Time Frame Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Samples were not collected due to early study termination.
Arm/Group Title Part 1: Participants With GCB-DLBCL Part 1: Participants With Solid Tumors
Hide Arm/Group Description:
At maximum tolerated or recommended phase II dose, participants with GCB-DLBCL were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
At maximum tolerated or recommended phase II dose, participants with solid tumors were enrolled in Part 1 expansion cohorts and received GSK2816126 twice-weekly, as intravenous solution.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
29.Secondary Outcome
Title Part 1:Concentration of GSK2816126 in Urine After Dosing at Steady State
Hide Description The amount of GSK2816126 excreted in urine after dosing at steady state was determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. Samples were not collected due to early termination of the study; therefore, no analysis could be performed.
Time Frame Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population Samples were not collected due to early study termination.
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly
Hide Arm/Group Description:
Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off).
Overall Number of Participants Analyzed 0 0 0 0 0 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
30.Secondary Outcome
Title Part 2: Number of Participants With SAEs and Non-SAEs
Hide Description An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. SAE is defined as any untoward medical occurrence that, at any dose results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/ incapacity, is a congenital anomaly/ birth defect, other situations and is associated with liver injury or impaired liver function. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
31.Secondary Outcome
Title Part 2: Number of Participants With DLTs
Hide Description An event was considered a DLT if it occurred within first 4 weeks (28 days) of treatment, and met the criteria's for hematologic , non-hematologic, infusion reactions and other toxicities, unless it can be clearly established that the event is unrelated to treatment. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
32.Secondary Outcome
Title Part 2: Number of Participants Withdrawn Due to AEs
Hide Description A participant was considered to have completed the study if they have completed their end of study visit or if the participant died or was still in follow-up at the time the study was closed or terminated. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
33.Secondary Outcome
Title Part 2: Number of Participants With Dose Interruptions
Hide Description The number of participants who had any dose interruptions were planned to be analyzed. However, this analysis was not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
34.Secondary Outcome
Title Part 2: Number of Participants With Dose Reductions
Hide Description The number of participants who had any dose reduction or delay were planned to be analyzed. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
35.Secondary Outcome
Title Part 2: Number of Participants With Worst Case Change From Baseline in Clinical Chemistry Parameters
Hide Description Blood samples were planned to be collected for evaluation of clinical chemistry parameters including direct bilirubin, chloride, LDH, total protein, urea/BUN and uric acid. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Baseline and up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
36.Secondary Outcome
Title Part 2: Number of Participants With Worst Case Changes From Baseline in Hematology Parameters
Hide Description Blood samples were planned to be collected for the analysis of hematology parameters including basophils, eosinophils, hematocrit, MCHC, MCH, MCV, monocytes, seg neutrophils, RBC count and reticulocytes. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Baseline and up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
37.Secondary Outcome
Title Part 2: Number of Participants With Abnormal Values for Vital Signs
Hide Description Vital sign measurements includes SBP, DBP, body temperature and heart rate. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
38.Secondary Outcome
Title Part 2: Number of Participants With Abnormal Findings for ECG Parameters
Hide Description Single measurements of 12-lead ECGs were planned to be obtained a semi-recumbent or semi-supine position after at least a 5 minutes rest using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT and QTc intervals. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
39.Secondary Outcome
Title Part 2: Clearance Following Administration of GSK2816126
Hide Description Blood samples were planned to be collected at Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1 and Day 11; Pre-dose on Day 4; Day 8, Day 11; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 pre-dose and within 5 minutes prior to end of infusion on Day 4 for population pharmacokinetic analysis of GSK2816126 including clearance. Each cycle was of 28 days. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
40.Secondary Outcome
Title Part 2: Volume of Distribution Following Administration of GSK2816126
Hide Description Blood samples were planned to be collected on Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1 and Day 11; Pre-dose on Day 4; Day 8,Day 11; Pre-dose on Day 15 for Cycle 1 and Cycle 2, 4, 6 and 12 pre-dose and within 5 minutes prior to end of infusion on Day 4 for population pharmacokinetic analysis of GSK2816126 including clearance. Each cycle was of 28 days. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
41.Secondary Outcome
Title Part 2:EC50 of GSK2816126 With Respect to Exposure Markers
Hide Description The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
42.Secondary Outcome
Title Part 2:Emax of GSK2816126 With Respect to Exposure Markers
Hide Description The pharmacokinetic/pharmacodynamic relationship between GSK2816126 exposure markers (dose, concentration, Cmax or AUC) was planned to be characterized by linear and/or non-linear mixed effect models. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
43.Secondary Outcome
Title Part 2: Number of Participants With Change in H3K27me3 Ratios Compared to Baseline
Hide Description The pre and post-treatment samples for tumor or surrogate tissue/body fluid (e.g. PBMCs, blood, skin or hair) were planned to be collected for the analysis of H3K27me3. Baseline was defined as the most recent, non-missing value prior to or on the first study treatment dose date. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Baseline and up to 3.2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
44.Secondary Outcome
Title Part 2: Concentration of GSK2816126 and Its Metabolites in Blood
Hide Description Blood samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Pre-dose, single draw between 0.5 and 1.9 hours from start of infusion, single draw between 3-6 hours following end of infusion on Day 1; Pre-dose on Day 15 for Cycle 1 and Cycles 2, 4, 6 and 12 (Each cycle was of 28 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
45.Secondary Outcome
Title Part 2: Concentration of GSK2816126 and Its Metabolites in Bile
Hide Description Bile samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites via the Entero-Test. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
46.Secondary Outcome
Title Part 2: Concentration of GSK2816126 and Its Metabolites in Urine
Hide Description Urine samples were planned to be collected from participants in the pharmacokinetic/pharmacodynamic expansion cohort for analysis of GSK2816126 and its metabolites. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
47.Secondary Outcome
Title Part 2:Concentration of GSK2816126 in Urine After Dosing at Steady State
Hide Description The amount of GSK2816126 excreted in urine after dosing at steady state was planned to be determined. The concentration of GSK2816126 in urine was planned to be measured with an investigational bio-analytical method and extrapolated to total amount excreted in urine over time using urine volume. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Pre-dose and 0 to 24 hours post-dose on Day 1; 0 to 8 hours post-dose on Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
48.Secondary Outcome
Title Part 2: Change in 4-beta-hydroxy Cholesterol to Cholesterol Ratio From Baseline Following Repeat Dosing of GSK2816126
Hide Description Plasma analysis for 4-beta-hydroxycholesterol and cholesterol was planned to be conducted. Baseline value was defined as the most recent, non-missing value from a local laboratory prior to the first dose of study treatment. Change from Baseline was defined as any visit value minus Baseline value. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Baseline and up to 21 days
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacodynamic Population. Data was not collected in Part2 as no participant was enrolled in Part2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
49.Secondary Outcome
Title Part 2: Duration of Response
Hide Description Duration of response for participants is defined as the time from the first documented evidence of a PR or CR until the first documented sign of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
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Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
50.Secondary Outcome
Title Part 2: Number of Participants With Progression Free Survival
Hide Description PFS is defined as the interval between the first dose of study medication and the earliest date of disease progression or death due to any cause. This analysis was planned but not performed for Part 2 as the study was terminated early during Part 1.
Time Frame Up to 3.2 years
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Hide Analysis Population Description
All Subjects Population. Data was not collected in Part 2 as no participant was enrolled in Part 2.
Arm/Group Title Part 2: All Participants
Hide Arm/Group Description:
Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Serious adverse events (SAEs) and non-serious adverse events (Non-SAEs) were collected in Part 1 from the start of the study treatment up to 3.2 years.
Adverse Event Reporting Description SAEs and Non-SAEs were collected in Part A from All Subjects Population which included all participants who receive at least one dose of study treatment. Data were not collected in Part 2 as no participant was enrolled in Part 2.
 
Arm/Group Title Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly Part 2: All Participants
Hide Arm/Group Description Eligible participants received GSK2816126 with a starting dose of 50 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 100 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 1200 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 1800 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 2400 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Eligible participants received GSK2816126 with a dose of 3000 mg twice-weekly, as an intravenous solution for 28 days (3 weeks on/1 week off). Participants with GCB-DLBCL-mutant and wild type, TFL-mutant and wild type as well as participants with MM were planned to be enrolled in Part 2 of the study. Participants enrolled in Part 2 were planned to receive RP2D .
All-Cause Mortality
Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly Part 2: All Participants
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      0/3 (0.00%)      1/4 (25.00%)      2/10 (20.00%)      0/12 (0.00%)      1/7 (14.29%)      0/0    
Hide Serious Adverse Events
Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly Part 2: All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/2 (50.00%)      0/1 (0.00%)      0/1 (0.00%)      0/1 (0.00%)      1/3 (33.33%)      2/4 (50.00%)      1/10 (10.00%)      5/12 (41.67%)      3/7 (42.86%)      0/0    
Gastrointestinal disorders                     
Enterocolitis  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Intestinal obstruction  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Vomiting  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
General disorders                     
Pyrexia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/10 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1 0/0  0
Infections and infestations                     
Respiratory tract infection  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Bronchitis  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Campylobacter infection  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Pneumonia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Skin bacterial infection  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Metabolism and nutrition disorders                     
Hypokalaemia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Musculoskeletal and connective tissue disorders                     
Back pain  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)                     
Tumour pain  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Respiratory, thoracic and mediastinal disorders                     
Haemoptysis  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
1
Term from vocabulary, MedDRA20.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part 1:GSK2816126 50 mg Twice-weekly Part 1:GSK2816126 100 mg Twice-weekly Part 1:GSK2816126 200 mg Twice-weekly Part 1:GSK2816126 400 mg Twice-weekly Part 1:GSK2816126 800 mg Twice-weekly Part 1:GSK2816126 1200 mg Twice-weekly Part 1:GSK2816126 1800 mg Twice-weekly Part 1:GSK2816126 2400 mg Twice-weekly Part 1:GSK2816126 3000 mg Twice-weekly Part 2: All Participants
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      1/1 (100.00%)      3/3 (100.00%)      4/4 (100.00%)      10/10 (100.00%)      12/12 (100.00%)      7/7 (100.00%)      0/0    
Blood and lymphatic system disorders                     
Anaemia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 2/3 (66.67%)  2 0/4 (0.00%)  0 3/10 (30.00%)  3 6/12 (50.00%)  6 1/7 (14.29%)  1 0/0  0
Thrombocytopenia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/10 (0.00%)  0 2/12 (16.67%)  2 1/7 (14.29%)  1 0/0  0
Lymphopenia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/10 (20.00%)  2 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Neutropenia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Febrile neutropenia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Cardiac disorders                     
Tachycardia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Atrial fibrillation  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Ear and labyrinth disorders                     
Ear disorder  1  0/2 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Eye disorders                     
Conjunctival hyperaemia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/10 (10.00%)  2 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Vision blurred  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Gastrointestinal disorders                     
Nausea  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/3 (66.67%)  3 2/4 (50.00%)  2 3/10 (30.00%)  6 9/12 (75.00%)  10 3/7 (42.86%)  6 0/0  0
Vomiting  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 2/3 (66.67%)  3 2/4 (50.00%)  3 2/10 (20.00%)  4 2/12 (16.67%)  2 3/7 (42.86%)  4 0/0  0
Constipation  1  1/2 (50.00%)  1 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 2/10 (20.00%)  2 1/12 (8.33%)  1 1/7 (14.29%)  1 0/0  0
Diarrhoea  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 1/4 (25.00%)  1 1/10 (10.00%)  1 2/12 (16.67%)  2 1/7 (14.29%)  1 0/0  0
Abdominal pain  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 2/4 (50.00%)  2 0/10 (0.00%)  0 0/12 (0.00%)  0 2/7 (28.57%)  3 0/0  0
Paraesthesia oral  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  2 0/4 (0.00%)  0 1/10 (10.00%)  1 2/12 (16.67%)  3 1/7 (14.29%)  2 0/0  0
Abdominal distension  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 1/10 (10.00%)  2 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Abdominal discomfort  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 2/10 (20.00%)  2 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Hypoaesthesia oral  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  2 0/0  0
Abdominal tenderness  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Anal paraesthesia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Dyspepsia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
Dysphagia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Gastrooesophageal reflux disease  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1 0/0  0
Oral dysaesthesia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Rectal tenesmus  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Stomatitis  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 0/7 (0.00%)  0 0/0  0
General disorders                     
Fatigue  1  0/2 (0.00%)  0 1/1 (100.00%)  1 1/1 (100.00%)  1 1/1 (100.00%)  1 2/3 (66.67%)  2 2/4 (50.00%)  2 6/10 (60.00%)  6 7/12 (58.33%)  7 2/7 (28.57%)  2 0/0  0
Pyrexia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/10 (0.00%)  0 1/12 (8.33%)  1 2/7 (28.57%)  2 0/0  0
Oedema peripheral  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/3 (33.33%)  1 0/4 (0.00%)  0 0/10 (0.00%)  0 2/12 (16.67%)  2 1/7 (14.29%)  1 0/0  0
Asthenia  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 0/4 (0.00%)  0 0/10 (0.00%)  0 1/12 (8.33%)  1 1/7 (14.29%)  1 0/0  0
Chest discomfort  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 1/1 (100.00%)  1 0/3 (0.00%)  0 0/4 (0.00%)  0 1/10 (10.00%)  1 0/12 (0.00%)  0 0/7 (0.00%)  0 0/0  0
Chills  1  0/2 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/1 (0.00%)  0 0/3 (0.00%)  0 1/4 (25.00%)  1 0/10 (0.00%)  0 0/12 (0.00%)  0 1/7 (14.29%)  1