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Uprosertib, Dabrafenib, and Trametinib in Treating Patients With Stage IIIC-IV Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01902173
Recruitment Status : Active, not recruiting
First Posted : July 18, 2013
Results First Posted : October 14, 2020
Last Update Posted : December 6, 2022
Sponsor:
Collaborators:
GlaxoSmithKline
Novartis Pharmaceuticals
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hematopoietic and Lymphoid Cell Neoplasm
Locally Advanced Malignant Solid Neoplasm
Locally Advanced Melanoma
Metastatic Malignant Solid Neoplasm
Metastatic Melanoma
Stage IIIC Cutaneous Melanoma AJCC v7
Stage IV Cutaneous Melanoma AJCC v6 and v7
Unresectable Malignant Solid Neoplasm
Unresectable Melanoma
Interventions Procedure: Biopsy
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Drug: Dabrafenib Mesylate
Procedure: Magnetic Resonance Imaging
Drug: Trametinib Dimethyl Sulfoxide
Drug: Uprosertib
Enrollment 27
Recruitment Details  
Pre-assignment Details 27 participants were enrolled, however 1 participant on the Dabrafenib + GSK2141795 75 mg arm and 1 participant on the Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg were found to be ineligible. Furthermore, 3 participants on the Dabrafenib + GSK2141795 75 mg arm did not receive protocol treatment were not evaluable for any study endpoint.
Arm/Group Title Dabrafenib + GSK2141795 50 mg Dabrafenib + GSK2141795 75 mg Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg
Hide Arm/Group Description Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily. Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily. Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily. Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily. Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily. Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily.
Period Title: Phase 1 Doublet Regimen Cohort 1
Started 3 0 0 0 0 0
Completed 0 0 0 0 0 0
Not Completed 3 0 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0             0
Progression/relapse             2             0             0             0             0             0
Period Title: Phase 1 Doublet Regimen Cohort 2
Started 0 9 0 0 0 0
Completed 0 0 0 0 0 0
Not Completed 0 9 0 0 0 0
Reason Not Completed
Progression/relapse             0             5             0             0             0             0
Ineligible             0             1             0             0             0             0
No treated             0             3             0             0             0             0
Period Title: Phase 1 Triplet Regimen Cohort 1
Started 0 0 4 0 0 0
Completed 0 0 0 0 0 0
Not Completed 0 0 4 0 0 0
Reason Not Completed
Progression/relapse             0             0             3             0             0             0
Ineligible             0             0             1             0             0             0
Period Title: Phase 1 Triplet Regimen Cohort 2
Started 0 0 0 3 0 0
Completed 0 0 0 0 0 0
Not Completed 0 0 0 3 0 0
Reason Not Completed
Ongoing treatment             0             0             0             1             0             0
Progression/relapse             0             0             0             2             0             0
Period Title: Phase 1 Triplet Regimen Cohort 3
Started 0 0 0 0 3 0
Completed 0 0 0 0 0 0
Not Completed 0 0 0 0 3 0
Reason Not Completed
Ongoing             0             0             0             0             1             0
Progression/relapse             0             0             0             0             2             0
Period Title: Phase 1 Triplet Regimen Cohort 4
Started 0 0 0 0 0 5
Completed 0 0 0 0 0 0
Not Completed 0 0 0 0 0 5
Reason Not Completed
Adverse Event             0             0             0             0             0             1
Progression/relapse             0             0             0             0             0             3
Death             0             0             0             0             0             1
Period Title: Phase II
Started 0 0 0 0 0 0
Completed 0 0 0 0 0 0
Not Completed 0 0 0 0 0 0
Arm/Group Title Dabrafenib + GSK2141795 50 mg Dabrafenib + GSK2141795 75 mg Dabrafenib + Trametinib 1.5mg + GSK2141795 25mg Dabrafenib + Trametinib 1.5mg + GSK2141795 50mg Dabrafenib + Trametinib 1.5mg + GSK2141795 75mg Dabrafenib + Trametinib 2.0mg + GSK2141795 75mg Total
Hide Arm/Group Description Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GSK2141795 once daily. Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GSK2141795 once daily Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25mg of GSK2141795 once daily. Triplet regimen cohort 2: participants were given 150mg of dabrafenib twice daily, 1.5mg of trametinib and 50mg of GSK2141795 once daily Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75mg of GSK2141795 once daily. Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GSK2141795 once daily. Total of all reporting groups
Overall Number of Baseline Participants 3 5 3 3 3 5 22
Hide Baseline Analysis Population Description
Total number of eligible and evaluable patients i.e. patients that received at least one dose of protocol therapy.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 3 participants 5 participants 3 participants 3 participants 3 participants 5 participants 22 participants
60.7
(52.0 to 65.8)
64.4
(40.5 to 70.2)
63.9
(45.7 to 68.5)
40.1
(18.5 to 57.5)
56.7
(28.5 to 70.2)
50.4
(48.8 to 77.1)
58.1
(18.5 to 77.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 3 participants 3 participants 5 participants 22 participants
Female
0
   0.0%
1
  20.0%
1
  33.3%
2
  66.7%
2
  66.7%
2
  40.0%
8
  36.4%
Male
3
 100.0%
4
  80.0%
2
  66.7%
1
  33.3%
1
  33.3%
3
  60.0%
14
  63.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 3 participants 3 participants 5 participants 22 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
3
 100.0%
5
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
5
 100.0%
21
  95.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
   4.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 3 participants 3 participants 5 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
3
 100.0%
5
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
5
 100.0%
21
  95.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
1
   4.5%
Prior BRAF inhibitor  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 3 participants 3 participants 5 participants 22 participants
Yes
2
  66.7%
4
  80.0%
1
  33.3%
1
  33.3%
2
  66.7%
3
  60.0%
13
  59.1%
No
1
  33.3%
1
  20.0%
2
  66.7%
2
  66.7%
1
  33.3%
1
  20.0%
8
  36.4%
Not reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  20.0%
1
   4.5%
Type of cancer  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 5 participants 3 participants 3 participants 3 participants 5 participants 22 participants
Melanoma
2
  66.7%
4
  80.0%
2
  66.7%
3
 100.0%
3
 100.0%
4
  80.0%
18
  81.8%
Lung
0
   0.0%
1
  20.0%
1
  33.3%
0
   0.0%
0
   0.0%
1
  20.0%
3
  13.6%
Thyroid
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.5%
1.Primary Outcome
Title Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib.
Hide Description MTD was evaluated by testing increasing doses up to 75 mg once a day, given in combination with dabrafenib dosed at 150 mg twice daily. MTD reflects the highest dose that did not cause a DLT. DLTs were defined as treatment regimen related: febrile neutropenia; Grade 4 neutropenia lasting more than 7 days; Grade 4 platelet count decrease; Grade 3-4 rash, fever, or hyperglycemia > 14 days, e) Grade 3-4 non-hematologic adverse events lasting greater than 7 days. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
Time Frame Every 2 weeks during days 1-56 of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible, analyzable and evaluable participants that were assessed for DLT. In the Dabrafenib + GSK2141795 75 mg arm, 1 participant was ineligible, 3 participants were not analyzable, and 1 participant did not satisfy protocol-specified criteria for DLT evaluation. These patients were excluded from DLT analysis.
Arm/Group Title Phase 1 Doublet Regimen
Hide Arm/Group Description:
All analyzable patients who experienced a dose limiting toxicity OR at least received GSK2141795 for 11 days in Cycle 1 and dabrafenib for 28 days in cycles 1 and 2 OR at least received GSK2141795 for 11 days in Cycle 1 and 50% of dabrafenib in Cycle 1
Overall Number of Participants Analyzed 7
Measure Type: Number
Unit of Measure: mg
75
2.Primary Outcome
Title Maximum-tolerated Dose (MTD) of Akt Inhibitor GSK2141795 in Combination With Dabrafenib and Trametinib.
Hide Description

MTD was evaluated by testing increasing doses up to 75 mg once a day, given in combination with dabrafenib dosed at 150 mg twice daily and trametinib at either 1.5 mg or 2 mg once a day. MTD reflects the highest dose that did not cause a dose-limiting toxicity (DLT). DLTs were defined as treatment regimen related: febrile neutropenia; Grade 4 neutropenia lasting more than 7 days; Grade 4 platelet count decrease; Grade 3-4 rash, fever, or hyperglycemia > 14 days, e) Grade 3-4 non-hematologic adverse events lasting greater than 7 days. Adverse events were graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Note: MTD for the triplet regimen could not be determined due to the end of supply of the study drug. Number reported is the maximum dose of GSK2141795 that was assessed in combination with 150 mg Dabrafenib and 2 mg trametinib.

Time Frame Every 2 weeks during days 1-56 of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable participants that were assessed for DLT. 1 participant in the Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg was not eligible. 1 participant in the Dabrafenib + Trametinib 2.0 mg + GSK2141795 75 mg arm did not satisfy protocol-specified criteria for DLT evaluation and was thus excluded.
Arm/Group Title Phase 1 Triplet Regimen
Hide Arm/Group Description:
All analyzable patients who experienced a dose limiting toxicity OR at least received GSK2141795 for 11 days in Cycle 1 and dabrafenib and trametinib for 28 days each in cycles 1 and 2 OR at least received GSK2141795 for 11 days in Cycle1 and 50% of dabrafenib and trametinib each in Cycle 1
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: mg
75
3.Primary Outcome
Title Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) as Assessed by RECIST Version 1.1 of the Doublet Regimen GSK2141795 + Dabrafenib at the Phase I Determined MTD. (Phase II)
Hide Description

All measurable lesions up to a maximum of 2 lesions per organ 5 lesions in total, representative of all involved organs, were identified as target lesions at baseline. All other lesions (or sites of disease) were identified as non-target lesions.

Complete Response (CR): Complete disappearance of all target and nontarget lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm.

Partial Response (PR): <= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.

Unconfirmed CR: One objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR.

Unconfirmed PR: One objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

Time Frame Disease assessments every 8 weeks for up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title Dabrafenib + GSK2141795 at MTD
Hide Arm/Group Description:
Patients who received at least one dose of protocol therapy at the Phase I determined MTD.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Primary Outcome
Title Objective Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses) as Assessed by RECIST Version 1.1 of the Triplet Regimen GSK2141795 + Dabrafenib + Trametinib at the Phase I Determined MTD. (Phase II)
Hide Description

All measurable lesions up to a maximum of 2 lesions per organ 5 lesions in total, representative of all involved organs, were identified as target lesions at baseline. All other lesions (or sites of disease) were identified as non-target lesions.

Complete Response (CR): Complete disappearance of all target and nontarget lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to < 1.0 cm.

Partial Response (PR): <= 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions.

Unconfirmed CR: One objective status of CR documented before progression or symptomatic deterioration but not qualifying as CR or PR.

Unconfirmed PR: One objective status of PR documented before progression or symptomatic deterioration but not qualifying as CR, PR or unconfirmed CR.

Time Frame Disease assessments every 8 weeks for up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title Dabrafenib + Trametinib + GSK2141795 at MTD
Hide Arm/Group Description:
Patients who received at least one dose of protocol therapy at the Phase I determined MTD.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Overall Survival (Phase II) of Patients Treated at the Phase I Determined MTD of Doublet Regimen
Hide Description Estimated with 95% confidence interval.
Time Frame From date of registration to date of death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title GSK2141795 + Dabrafenib at the Phase I Determined MTD
Hide Arm/Group Description:
Patients who received at least 1 dose of protocol therapy at the Phase I determined MTD
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Overall Survival (Phase II) of Patients Treated at the Phase I Determined MTD of Triplet Regimen
Hide Description Estimated with 95% confidence interval.
Time Frame From date of registration to date of death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title GSK2141795 + Dabrafenib + Trametinib at Phase I Determined MTD
Hide Arm/Group Description:
Patients who received at least 1 dose of protocol therapy at the Phase I determined MTD
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Progression-free Survival as Assessed by RECIST Version 1.1 of the Doublet Regimen at the Phase I Determined MTD (Phase II)
Hide Description Estimated with 95% confidence interval.
Time Frame From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title Dabrafenib + GSK2141795 at Phase I Determined MTD
Hide Arm/Group Description:
Patients who received at least one dose of protocol therapy at the Phase I determined MTD.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Progression-free Survival as Assessed by RECIST Version 1.1 of the Triplet Regimen at the Phase I Determined MTD (Phase II)
Hide Description Estimated with 95% confidence interval.
Time Frame From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title Dabrafenib + Trametinib + GSK2141795 at Phase I Determined MTD
Hide Arm/Group Description:
Patients who received at least one dose of protocol therapy at the phase I determined MTD
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Toxicity Rate of MTD Graded by the NCI CTCAE Version 4.0 (Phase II)
Hide Description [Not Specified]
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were enrolled to the Phase II portion due to the end of the supply of GSK2141795
Arm/Group Title Dabrafenib + GSK2141795 75 mg
Hide Arm/Group Description:
All participants on the Phase II triplet combination of dabrafenib, trametinib and GSK2141795 MTD .
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
10.Other Pre-specified Outcome
Title Pharmacokinetic Parameters
Hide Description [Not Specified]
Time Frame Baseline, pre-dose and 1, 2, 4, and 8 hours on day 15, and pre-dose day 29
Outcome Measure Data Not Reported
11.Other Pre-specified Outcome
Title Prevalence of Markers
Hide Description For binary markers, the prevalence will be able to be estimated and exact binomial confidence interval will be calculated. The association between these categorical markers and clinical outcomes will be explored in a preliminary manner, using Fisher's exact test to compare response and a logrank test to compare Kaplan-Meier estimates of overall survival and progression free survival between marker positive and marker negative groups.
Time Frame Up to 3 years
Outcome Measure Data Not Reported
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dabrafenib + GSK2141795 50 mg Dabrafenib + GSK2141795 75 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
Hide Arm/Group Description Doublet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily and 50 mg of GK2141795 once daily. Doublet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily and 75 mg of GK2141795 once daily. Triplet regimen cohort 1: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 25 mg of GK2141795 once daily. Triplet regimen cohort 2: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 50 mg of GK2141795 once daily. Triplet regimen cohort 3: participants were given 150 mg of dabrafenib twice daily, 1.5 mg of trametinib and 75 mg of GK2141795 once daily. Triplet regimen cohort 4: participants were given 150 mg of dabrafenib twice daily, 2 mg of trametinib and 75 mg of GK2141795 once daily.
All-Cause Mortality
Dabrafenib + GSK2141795 50 mg Dabrafenib + GSK2141795 75 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   3/5 (60.00%)   2/3 (66.67%)   2/3 (66.67%)   2/3 (66.67%)   4/5 (80.00%) 
Hide Serious Adverse Events
Dabrafenib + GSK2141795 50 mg Dabrafenib + GSK2141795 75 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/3 (66.67%)   2/5 (40.00%)   2/3 (66.67%)   1/3 (33.33%)   1/3 (33.33%)   5/5 (100.00%) 
Cardiac disorders             
Atrial fibrillation   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Gastrointestinal disorders             
Abdominal pain   0/3 (0.00%)  2/5 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Nausea   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Small intestinal obstruction   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Upper gastrointestinal hemorrhage   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
General disorders             
Fatigue   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Fever   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/5 (60.00%) 
General disorders and admin site conditions - Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Localized edema   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Non-cardiac chest pain   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Immune system disorders             
Allergic reaction   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Infections and infestations             
Lung infection   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Sepsis   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Urinary tract infection   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Metabolism and nutrition disorders             
Dehydration   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Hypercalcemia   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Hyperglycemia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypokalemia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyponatremia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Hypophosphatemia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tissue disorders             
Flank pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pain in extremity   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Neoplasms benign, malignant and unspecified - Other   1/3 (33.33%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  2/5 (40.00%) 
Tumor pain   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Nervous system disorders             
Seizure   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Syncope   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Psychiatric disorders             
Confusion   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders             
Rash maculo-papular   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders - Other   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Vascular disorders             
Thromboembolic event   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dabrafenib + GSK2141795 50 mg Dabrafenib + GSK2141795 75 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 25 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 50 mg Dabrafenib + Trametinib 1.5 mg + GSK2141795 75 mg Dabrafenib + Trametinib 2 mg + GSK2141795 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   5/5 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   5/5 (100.00%) 
Blood and lymphatic system disorders             
Anemia   1/3 (33.33%)  3/5 (60.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Febrile neutropenia   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Cardiac disorders             
Cardiac disorders-Other   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Sinus tachycardia   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Congenital, familial and genetic disorders             
Congenital, familial and genetic disorders - Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Ear and labyrinth disorders             
Ear pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Tinnitus   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Eye disorders             
Dry eye   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Eye disorders-Other   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Flashing lights   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Uveitis   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Gastrointestinal disorders             
Abdominal pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/5 (0.00%) 
Ascites   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Constipation   1/3 (33.33%)  0/5 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/3 (0.00%)  3/5 (60.00%) 
Diarrhea   1/3 (33.33%)  2/5 (40.00%)  1/3 (33.33%)  0/3 (0.00%)  2/3 (66.67%)  2/5 (40.00%) 
Dyspepsia   0/3 (0.00%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Gastroesophageal reflux disease   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Gastrointestinal disorders-Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Mucositis oral   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Nausea   2/3 (66.67%)  3/5 (60.00%)  1/3 (33.33%)  1/3 (33.33%)  3/3 (100.00%)  3/5 (60.00%) 
Vomiting   2/3 (66.67%)  2/5 (40.00%)  2/3 (66.67%)  2/3 (66.67%)  1/3 (33.33%)  2/5 (40.00%) 
General disorders             
Chills   1/3 (33.33%)  2/5 (40.00%)  2/3 (66.67%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Edema limbs   2/3 (66.67%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Fatigue   3/3 (100.00%)  3/5 (60.00%)  3/3 (100.00%)  1/3 (33.33%)  1/3 (33.33%)  3/5 (60.00%) 
Fever   1/3 (33.33%)  1/5 (20.00%)  2/3 (66.67%)  2/3 (66.67%)  1/3 (33.33%)  2/5 (40.00%) 
Flu like symptoms   1/3 (33.33%)  2/5 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Gait disturbance   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
General disorders and admin site conditions - Other   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Irritability   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Malaise   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Non-cardiac chest pain   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Hepatobiliary disorders             
Gallbladder obstruction   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Immune system disorders             
Allergic reaction   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Infections and infestations             
Bronchial infection   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Infections and infestations-Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Lung infection   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Otitis media   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Papulopustular rash   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pharyngitis   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Sepsis   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Sinusitis   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Soft tissue infection   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Upper respiratory infection   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/5 (20.00%) 
Urinary tract infection   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Injury, poisoning and procedural complications             
Bruising   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Fall   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Injury, poison and procedural complications - Other   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Investigations             
Activated partial thromboplastin time prolonged   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Alanine aminotransferase increased   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  1/5 (20.00%) 
Alkaline phosphatase increased   1/3 (33.33%)  0/5 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/3 (33.33%)  0/5 (0.00%) 
Aspartate aminotransferase increased   1/3 (33.33%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Creatinine increased   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
INR increased   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Investigations-Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/5 (0.00%) 
Lipase increased   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Lymphocyte count decreased   2/3 (66.67%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Neutrophil count decreased   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  3/5 (60.00%) 
Platelet count decreased   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Weight loss   2/3 (66.67%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
White blood cell decreased   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  3/5 (60.00%) 
Metabolism and nutrition disorders             
Anorexia   2/3 (66.67%)  3/5 (60.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Dehydration   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/5 (40.00%) 
Hypercalcemia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyperglycemia   2/3 (66.67%)  2/5 (40.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Hypernatremia   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypoalbuminemia   1/3 (33.33%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Hypocalcemia   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypokalemia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Hypomagnesemia   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Hyponatremia   1/3 (33.33%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Hypophosphatemia   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Musculoskeletal and connective tissue disorders             
Arthralgia   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Back pain   0/3 (0.00%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Bone pain   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Chest wall pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Flank pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Generalized muscle weakness   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/5 (40.00%) 
Joint effusion   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Muscle weakness upper limb   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Musculoskeletal and connective tiss disorder - Other   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Myalgia   2/3 (66.67%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Neck pain   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/5 (20.00%) 
Pain in extremity   2/3 (66.67%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  2/5 (40.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)             
Neoplasms benign, malignant and unspecified - Other   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Tumor pain   0/3 (0.00%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Nervous system disorders             
Dizziness   1/3 (33.33%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Dysphasia   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Headache   0/3 (0.00%)  2/5 (40.00%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  3/5 (60.00%) 
Nervous system disorders-Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Peripheral sensory neuropathy   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Presyncope   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Sinus pain   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/5 (0.00%) 
Somnolence   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Tremor   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Vasovagal reaction   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Psychiatric disorders             
Anxiety   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/5 (20.00%) 
Confusion   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Depression   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Insomnia   1/3 (33.33%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Psychiatric disorders-Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders             
Hematuria   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Proteinuria   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Renal and urinary disorders-Other   0/3 (0.00%)  2/5 (40.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Urinary frequency   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Urinary incontinence   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Reproductive system and breast disorders             
Vaginal inflammation   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders             
Allergic rhinitis   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/5 (0.00%) 
Cough   1/3 (33.33%)  2/5 (40.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Dyspnea   2/3 (66.67%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Epistaxis   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Hypoxia   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Nasal congestion   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/5 (20.00%) 
Pleuritic pain   2/3 (66.67%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pneumonitis   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Postnasal drip   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Productive cough   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Resp, thoracic and mediastinal disorders - Other   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Sore throat   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Skin and subcutaneous tissue disorders             
Alopecia   0/3 (0.00%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Bullous dermatitis   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Dry skin   0/3 (0.00%)  1/5 (20.00%)  2/3 (66.67%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Erythema multiforme   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hyperhidrosis   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Nail discoloration   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Nail ridging   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pain of skin   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Palmar-plantar erythrodysesthesia syndrome   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Photosensitivity   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Pruritus   1/3 (33.33%)  1/5 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/5 (0.00%) 
Rash acneiform   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Rash maculo-papular   1/3 (33.33%)  2/5 (40.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  3/5 (60.00%) 
Scalp pain   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Skin and subcutaneous tissue disorders - Other   1/3 (33.33%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Skin hypopigmentation   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Telangiectasia   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Urticaria   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Vascular disorders             
Capillary leak syndrome   0/3 (0.00%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/5 (40.00%) 
Flushing   0/3 (0.00%)  1/5 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Hypertension   0/3 (0.00%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/5 (20.00%) 
Hypotension   1/3 (33.33%)  0/5 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  1/5 (20.00%) 
Thromboembolic event   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Vascular disorders-Other   1/3 (33.33%)  0/5 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/5 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Melanoma Statistician
Organization: SWOG
Phone: 2066674623
EMail: jmoon@fredhutch.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01902173    
Other Study ID Numbers: NCI-2013-01320
NCI-2013-01320 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SWOG-S1221
S1221 ( Other Identifier: SWOG )
S1221 ( Other Identifier: CTEP )
U10CA180830 ( U.S. NIH Grant/Contract )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: July 15, 2013
First Posted: July 18, 2013
Results First Submitted: May 13, 2019
Results First Posted: October 14, 2020
Last Update Posted: December 6, 2022