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Trial record 15 of 881 for:    "Reticulum Cell Sarcoma"

Study of Brentuximab Vedotin (SGN-35) in Pediatric Participants With Relapsed or Refractory (r/r) Systemic Anaplastic Large-Cell Lymphoma or Hodgkin Lymphoma

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: NCT01492088
Recruitment Status : Completed
First Posted : December 14, 2011
Results First Posted : May 15, 2017
Last Update Posted : November 20, 2018
Sponsor:
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Relapsed or Refractory Hodgkin Lymphoma
Relapsed or Refractory Anaplastic Large-cell Lymphoma
Intervention Drug: Brentuximab vedotin
Enrollment 36
Recruitment Details Participants took part in the study at 12 investigative sites in United States, France, Germany, Netherlands, United Kingdom, Italy, Spain and Mexico from 16-April-2012 to 12-April-2018.
Pre-assignment Details Participants with diagnosis of relapsed or refractory (r/r) sALCL/HL were enrolled to receive brentuximab vedotin 1.4-1.8 mg/kg, intravenous infusion on Day 1 of every 21-day cycle for up to 16 cycles. Treatment beyond 16 cycles was permitted at joint discretion of sponsor and investigator for participants experiencing continued clinical benefit.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity. Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit. Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Period Title: Overall Study
Started 3 16 17
Completed 0 2 3
Not Completed 3 14 14
Reason Not Completed
Withdrawal by Patient             0             2             0
Death             1             6             2
Completed Post Treatment Followup (PTFU)             2             0             1
Alive at Last Follow-up             0             6             11
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only Total
Hide Arm/Group Description Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity. Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit. Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit. Total of all reporting groups
Overall Number of Baseline Participants 3 16 17 36
Hide Baseline Analysis Population Description
Safety population is defined as participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 16 participants 17 participants 36 participants
14.7  (1.15) 14.5  (2.68) 11.5  (3.18) 13.1  (3.19)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 16 participants 17 participants 36 participants
Female
1
  33.3%
7
  43.8%
3
  17.6%
11
  30.6%
Male
2
  66.7%
9
  56.3%
14
  82.4%
25
  69.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 16 participants 17 participants 36 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
4
  23.5%
4
  11.1%
Not Hispanic or Latino
3
 100.0%
14
  87.5%
12
  70.6%
29
  80.6%
Unknown or Not Reported
0
   0.0%
2
  12.5%
1
   5.9%
3
   8.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 16 participants 17 participants 36 participants
White
2
  66.7%
13
  81.3%
16
  94.1%
31
  86.1%
Asian
1
  33.3%
0
   0.0%
1
   5.9%
2
   5.6%
Other
0
   0.0%
2
  12.5%
0
   0.0%
2
   5.6%
Not Reported
0
   0.0%
1
   6.3%
0
   0.0%
1
   2.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 16 participants 17 participants 36 participants
United States
2
  66.7%
1
   6.3%
1
   5.9%
4
  11.1%
France
0
   0.0%
2
  12.5%
0
   0.0%
2
   5.6%
Germany
0
   0.0%
4
  25.0%
1
   5.9%
5
  13.9%
Netherlands
0
   0.0%
1
   6.3%
2
  11.8%
3
   8.3%
United Kingdom
0
   0.0%
1
   6.3%
2
  11.8%
3
   8.3%
Italy
1
  33.3%
7
  43.8%
6
  35.3%
14
  38.9%
Spain
0
   0.0%
0
   0.0%
4
  23.5%
4
  11.1%
Mexico
0
   0.0%
0
   0.0%
1
   5.9%
1
   2.8%
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 3 participants 16 participants 17 participants 36 participants
167.17  (10.865) 165.31  (14.350) 149.54  (17.783) 158.02  (17.493)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 3 participants 16 participants 17 participants 36 participants
53.10  (9.924) 57.85  (17.539) 42.16  (15.162) 50.04  (17.361)
Body Surface Area  
Mean (Standard Deviation)
Unit of measure:  M^2
Number Analyzed 3 participants 16 participants 17 participants 36 participants
1.562  (0.0967) 1.617  (0.2938) 1.313  (0.3103) 1.469  (0.3228)
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1)
Hide Description An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A Serious Adverse Event (SAE) is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
TEAE
3
 100.0%
9
 100.0%
SAE
0
   0.0%
4
  44.4%
2.Primary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1)
Hide Description Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Time Frame From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
Gamma-glutamyltransferase increased
0
   0.0%
1
  11.1%
Transaminases increased
0
   0.0%
1
  11.1%
Lymphocyte count decreased
1
  33.3%
1
  11.1%
Neutrophil count decreased
0
   0.0%
1
  11.1%
Blood bicarbonate decreased
0
   0.0%
1
  11.1%
Weight decreased
0
   0.0%
1
  11.1%
Hypocalaemia
0
   0.0%
2
  22.2%
Hyperuricaemia
0
   0.0%
1
  11.1%
3.Primary Outcome
Title Number of Participants With Clinically Significant Vital Signs Values Reported as AEs (Phase 1)
Hide Description Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
Time Frame From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Participants enrolled in Phase 1 of study were evaluated for this outcome measure.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 9
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1)
Hide Description Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
Time Frame Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 19.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Primary Outcome
Title Serum Concentration of Total Antibodies (Conjugated and Unconjugated) (Phase 1)
Hide Description Blood samples were collected and tested for conjugated and unconjugated antibodies.
Time Frame Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 20.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Primary Outcome
Title Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1)
Hide Description Blood samples were collected and tested for MMAE plasma concentrations.
Time Frame Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Data for this outcome measure was not summarized for Phase 1 participants only, data was summarized together for Phase 1 and 2 participants in brentuximab 1.4 mg/kg and 1.8 mg/kg arms groups. Data has been presented in OM 21.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Primary Outcome
Title Overall Response Rate (ORR) (Phase 1 and 2)
Hide Description Overall response rate is defined as the percentage of participants with complete remission (CR) or partial remission (PR) as assessed by an independent review facility (IRF) using International Working Group (IWG) Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or end of treatment (EOT) (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 15 17
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 71)
47
(21 to 73)
53
(28 to 77)
8.Secondary Outcome
Title Number of Participants With Antitherapeutic Antibodies (ATA) and Neutralizing ATA (nATA) (Phase 1 and 2)
Hide Description Blood samples were collected to assess the immunogenicity of brentuximab vedotin (ATA and nATA development) using a laboratory test. ATA-positive samples were further characterized as transiently ATA positive (defined as 1 or 2 post-Baseline ATA-positive responses), persistently ATA positive (defined as more than 2 post-Baseline ATA positive responses), and nATA positive or negative.
Time Frame Baseline up to EOT (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
ATA status: Transiently positive
1
  33.3%
4
  25.0%
7
  41.2%
ATA status: Persistently positive
0
   0.0%
2
  12.5%
0
   0.0%
nATA status: Positive
0
   0.0%
5
  31.3%
4
  23.5%
9.Secondary Outcome
Title Overall Response Rate (ORR) (Phase 1)
Hide Description Overall response rate is defined as the percentage of participants with CR or PR as assessed by an IRF using IWG Revised Response Criteria for Malignant Lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Participants enrolled in Phase 1 of the study were evaluated for this outcome measure.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 8
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 71)
63
(24 to 91)
10.Secondary Outcome
Title Time to Progression (TTP) (Phase 1 and 2)
Hide Description TTP is defined as the time in months from first dose until the first subsequent documentation of objective tumor progression. Progressive disease (PD) is defined as any new lesion or increase by ≥50% of previously involved sites from nadir.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. TTP was censored on last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.4 to 2.8)
4.8 [1] 
(1.2 to NA)
6.2 [1] 
(2.8 to NA)
[1]
Upper limit of CI was not reached due to low number of participants with events.
11.Secondary Outcome
Title Time to Response (Phase 1 and 2)
Hide Description Time to response is defined as the time in months from the first dose of study treatment until the date of the first assessment of confirmed CR or PR. as assessed by an IRF using IWG revised response criteria for malignant lymphoma. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Response-evaluable population included participants who received at least 1 dose of study drug, have measurable disease at baseline, and 1 postbaseline disease assessment. Time to response was censored on the last radiological assessment of measured lesions documenting absence of CR or PR for participants who did not have CR or PR.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 15 17
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
2.7 [2] 
(1.3 to NA)
1.5 [2] 
(1.2 to NA)
[1]
Median was not reached as no participant had response.
[2]
Upper limit of CI was not reached due to low number of participants with events.
12.Secondary Outcome
Title Duration of Response (DOR) (Phase 1 and 2)
Hide Description DOR is defined as the time in months from the date of first documentation of a CR or PR to the date of first documentation of tumor progression or PD per IRF assessment according to IWG criteria or to death due to any cause, whichever comes first. CR is defined as the disappearance of all evidence of disease and PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with response from the Safety Population, all enrolled participants who received at least one dose of brentuximab vedotin, with data available for analysis. Duration of response was censored at last observation documenting absence of PD for participants who did not have tumor progression.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 0 7 9
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(2.2 to NA)
30.3
(3.4 to 30.3)
[1]
Median and upper limit of CI was not reached due to low number of participants with events.
13.Secondary Outcome
Title Event Free Survival (EFS) (Phase 1 and 2)
Hide Description EFS is defined as the time in months from first dose until any cause of treatment failure: disease progression, premature discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death (Up to 27 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. EFS was censored on the last follow-up date if none of the above events occur during the study.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.4 to 2.8)
2.1
(1.2 to 4.8)
4.8
(2.8 to 7.4)
14.Secondary Outcome
Title Progression Free Survival (PFS) (Phase 1 and 2)
Hide Description PFS is defined as time in months from start of study treatment to first documentation of objective tumor progression per IRF assessment or up to death due to any cause, whichever occurs first. PD is defined as any new lesion or increase by >50% of previously involved sites from nadir.
Time Frame Cycles 2, 4, 7, 10, 13 and 16 (21-day cycles) until disease progression, death or EOT and then every 12 weeks for 12 months after EOT, until disease progression, or death or end of study (Up to 72 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. PFS was censored on the day following the date of last radiological assessment of measured lesions documenting absence of PD for participants who did not have tumor progression.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.4 to 2.8)
3.8 [1] 
(1.2 to NA)
6.2
(2.8 to 31.5)
[1]
Upper limit of CI was not reached due to low number of participants with events.
15.Secondary Outcome
Title Overall Survival (OS) (Phase 1 and 2)
Hide Description OS is the time in months from start of study treatment to date of death due to any cause.
Time Frame Every 6 months after EOT, until the sooner of death, study closure, or 2 years after enrolment of the last participant (Up to 72 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
Median was not reached due to low number of participants with events.
16.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (Phase 1 and 2)
Hide Description An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A SAE is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. AE severity was graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time Frame From the first dose through 30 days after the last dose of study medication (up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
3
 100.0%
16
 100.0%
17
 100.0%
SAEs
0
   0.0%
7
  43.8%
1
   5.9%
17.Secondary Outcome
Title Number of Participants With Abnormal Clinical Laboratory Values Reported as AEs (Phase 1 and 2)
Hide Description Abnormal clinical laboratory values (serum chemistry and hematology) were reported as AEs if they were considered by the investigator to be a clinically significant change from Baseline or led to premature discontinuation of study treatment, dose modification, or other therapeutic intervention.
Time Frame From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
Gamma-glutamyltransferase increased
0
   0.0%
2
  12.5%
0
   0.0%
Alanine aminotransferase increased
0
   0.0%
1
   6.3%
0
   0.0%
Aspartate aminotransferase increased
0
   0.0%
1
   6.3%
0
   0.0%
Transaminases increased
0
   0.0%
1
   6.3%
0
   0.0%
Lymphocyte count decreased
1
  33.3%
0
   0.0%
2
  11.8%
Neutrophil count decreased
0
   0.0%
0
   0.0%
2
  11.8%
White blood cell count decreased
0
   0.0%
0
   0.0%
1
   5.9%
Blood bicarbonate decreased
0
   0.0%
1
   6.3%
0
   0.0%
Weight decreased
0
   0.0%
0
   0.0%
1
   5.9%
C-reactive protein increased
0
   0.0%
1
   6.3%
0
   0.0%
Blood alkaline phosphatase increased
0
   0.0%
1
   6.3%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Clinically Significant Vital Signs Reported as AEs (Phase 1 and 2)
Hide Description Vital signs measurements included supine (after 3-5 minutes in this position) and standing (after 3-5 minutes in this position) measurements of diastolic and systolic blood pressure, heart rate, and oral temperature.
Time Frame From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population is defined as all participants who received at least 1 dose of study drug. Data was summarized together for Phase 1 and 2 participants in brentuximab 1.8 mg/kg arm group.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 16 17
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
19.Secondary Outcome
Title Antibody-drug Conjugate (ADC) Serum Concentrations (Phase 1 and 2)
Hide Description Blood samples were collected and tested for serum concentrations of brentuximab vedotin antibody-drug conjugate.
Time Frame Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 33
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1 Day 1, Pre-Dose Number Analyzed 0 participants 33 participants
NA [1]   (NA)
Cycle 1 Day 1, 5 Minutes Post-Dose Number Analyzed 3 participants 33 participants
23.1  (3.46) 31.8  (12.4)
Cycle 1 Day 2, 24 Hours Post-Dose Number Analyzed 3 participants 32 participants
9.50  (1.73) 13.0  (5.34)
Cycle 1 Day 3, 48 Hours Post-Dose Number Analyzed 3 participants 31 participants
5.67  (0.924) 12.0  (16.3)
Cycle 1 Day 5, 96 Hours Post-Dose Number Analyzed 3 participants 31 participants
3.50  (1.41) 8.68  (13.4)
Cycle 1 Day 14, 312 Hours Post-Dose Number Analyzed 3 participants 31 participants
0.844  (0.309) 2.19  (3.44)
Cycle 2 Day 1, Pre-Dose Number Analyzed 3 participants 32 participants
0.149  (0.128) 0.395  (0.322)
Cycle 2 Day 1, 5-minutes Post-Dose Number Analyzed 3 participants 30 participants
25.3  (7.56) 32.9  (9.80)
Cycle 2 Day 2, 24 Hours Post-Dose Number Analyzed 3 participants 10 participants
8.80  (6.19) 10.4  (8.05)
Cycle 2 Day 3, 48 Hours Post-Dose Number Analyzed 3 participants 29 participants
3.70  (1.95) 11.4  (16.8)
Cycle 2 Day 5, 96 Hours Post-Dose Number Analyzed 3 participants 27 participants
2.04  (1.26) 9.61  (17.9)
Cycle 3 Day 1, Pre-Dose Number Analyzed 2 participants 26 participants
0.116  (0.163) 0.491  (0.387)
Cycle 3 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 26 participants
23.9  (2.83) 31.3  (9.79)
Cycle 4 Day 1, Pre-dose Number Analyzed 2 participants 21 participants
0.218  (0.271) 0.691  (0.492)
Cycle 4 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 21 participants
22.9  (4.60) 30.0  (12.2)
Cycle 5 Day 1, Pre-Dose Number Analyzed 2 participants 21 participants
0.264  (0.321) 0.845  (0.564)
Cycle 5 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 21 participants
22.5  (3.32) 30.6  (15.1)
Cycle 6 Day 1, Pre-Dose Number Analyzed 2 participants 17 participants
0.312  (0.351) 1.06  (0.699)
Cycle 6 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 17 participants
20.3  (4.38) 33.2  (16.1)
Cycle 7 Day 1, Pre-Dose Number Analyzed 2 participants 17 participants
0.327  (0.337) 1.04  (0.618)
Cycle 7 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 17 participants
17.9  (2.40) 32.3  (15.4)
Cycle 8 Day 1, Pre-Dose Number Analyzed 0 participants 14 participants
1.25  (0.565)
Cycle 8 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 14 participants
35.2  (10.5)
Cycle 8 Day 2, 24 Hours Post-Dose Number Analyzed 0 participants 13 participants
14.0  (4.55)
Cycle 8 Day 3, 48 Hours Post-Dose Number Analyzed 0 participants 13 participants
9.53  (2.96)
Cycle 8 Day 5, 96 Hours Post-Dose Number Analyzed 0 participants 12 participants
6.44  (2.35)
Cycle 8 Day 14, 312 Hours Post-Dose Number Analyzed 0 participants 13 participants
3.30  (4.63)
Cycle 9 Day 1, Pre-Dose Number Analyzed 0 participants 14 participants
4.37  (11.7)
Cycle 9 Day 1, 5 Minutes Post-Dose Number Analyzed 0 participants 13 participants
29.6  (11.3)
Cycle 10 Day 1, Pre-Dose Number Analyzed 0 participants 11 participants
1.20  (0.455)
Cycle 10 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 12 participants
35.7  (9.50)
Cycle 11 Day 1, Pre-Dose Number Analyzed 0 participants 8 participants
1.84  (1.57)
Cycle 11 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 8 participants
35.7  (10.8)
Cycle 12 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
1.47  (0.665)
Cycle 12 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
40.0  (10.4)
Cycle 13 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
6.28  (11.5)
Cycle 13 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
33.3  (16.1)
Cycle 14 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
1.60  (0.600)
Cycle 14 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
37.0  (7.92)
Cycle 15 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
1.48  (0.542)
Cycle 15 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
40.3  (10.6)
Cycle 16 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
1.52  (0.361)
Cycle 16 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
41.5  (4.70)
[1]
Data was below the limit of quantification.
20.Secondary Outcome
Title Serum Concentration of Total Antibodies (Conjugated and Unconjugated)
Hide Description Blood samples were collected and tested for conjugated and unconjugated antibodies.
Time Frame Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 33
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1 Day 1, Pre-Dose Number Analyzed 2 participants 32 participants
NA [1]   (NA) NA [1]   (NA)
Cycle 1 Day 1, 5 Minutes Post-Dose Number Analyzed 3 participants 33 participants
26.3  (2.29) 34.7  (13.4)
Cycle 1 Day 2, 24 Hours Post-Dose Number Analyzed 3 participants 33 participants
16.7  (1.50) 25.0  (9.59)
Cycle 1 Day 3, 48 Hours Post-Dose Number Analyzed 3 participants 33 participants
12.7  (3.13) 18.5  (7.57)
Cycle 1 Day 5, 96 Hours Post-Dose Number Analyzed 3 participants 33 participants
8.63  (5.11) 11.8  (5.02)
Cycle 1 Day 14, 312 Hours Post-Dose Number Analyzed 3 participants 32 participants
2.23  (0.833) 3.50  (1.70)
Cycle 2 Day 1, Pre-Dose Number Analyzed 3 participants 32 participants
0.470  (0.459) 1.16  (0.825)
Cycle 2 Day 1, 5-minutes Post-Dose Number Analyzed 3 participants 31 participants
26.9  (7.98) 35.6  (12.0)
Cycle 2 Day 2, 24 Hours Post-Dose Number Analyzed 3 participants 10 participants
17.1  (10.4) 17.2  (7.93)
Cycle 2 Day 3, 48 Hours Post-Dose Number Analyzed 3 participants 31 participants
9.60  (5.39) 16.0  (6.73)
Cycle 2 Day 3, 96 Hours Post-Dose Number Analyzed 3 participants 30 participants
6.43  (3.69) 10.2  (5.16)
Cycle 3 Day 1, Pre-Dose Number Analyzed 2 participants 26 participants
0.415  (0.586) 1.62  (1.07)
Cycle 3 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 26 participants
30.0  (5.87) 38.2  (13.1)
Cycle 4 Day 1, Pre-dose Number Analyzed 2 participants 21 participants
0.875  (1.03) 1.95  (1.26)
Cycle 4 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 21 participants
29.6  (8.13) 37.1  (15.6)
Cycle 5 Day 1, Pre-Dose Number Analyzed 2 participants 21 participants
0.844  (0.928) 2.45  (1.68)
Cycle 5 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 21 participants
29.4  (3.04) 38.0  (18.8)
Cycle 6 Day 1, Pre-Dose Number Analyzed 2 participants 17 participants
1.05  (1.20) 2.99  (1.81)
Cycle 6 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 17 participants
29.4  (5.37) 39.8  (19.8)
Cycle 7 Day 1, Pre-Dose Number Analyzed 2 participants 17 participants
0.995  (0.998) 2.92  (1.62)
Cycle 7 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 17 participants
24.0  (2.69) 41.0  (21.2)
Cycle 8 Day 1, Pre-Dose Number Analyzed 0 participants 14 participants
3.29  (1.14)
Cycle 8 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 14 participants
41.4  (9.47)
Cycle 8 Day 2, 24 Hours Post-Dose Number Analyzed 0 participants 14 participants
28.2  (6.38)
Cycle 8 Day 3, 48 Hours Post-Dose Number Analyzed 0 participants 14 participants
22.9  (5.67)
Cycle 8 Day 5, 96 Hours Post-Dose Number Analyzed 0 participants 14 participants
17.3  (4.93)
Cycle 8 Day 14, 312 Hours Post-Dose Number Analyzed 0 participants 13 participants
5.74  (2.02)
Cycle 9 Day 1, Pre-Dose Number Analyzed 0 participants 14 participants
6.30  (12.0)
Cycle 9 Day 1, 5 Minutes Post-Dose Number Analyzed 0 participants 13 participants
35.1  (11.3)
Cycle 10 Day 1, Pre-Dose Number Analyzed 0 participants 12 participants
3.48  (1.13)
Cycle 10 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 12 participants
41.4  (8.63)
Cycle 11 Day 1, Pre-Dose Number Analyzed 0 participants 8 participants
3.96  (2.24)
Cycle 11 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 8 participants
42.8  (8.85)
Cycle 12 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
3.47  (1.28)
Cycle 12 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
44.8  (10.3)
Cycle 13 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
11.3  (17.1)
Cycle 13 Day 1, 5 minutes Post-Dose Number Analyzed 3 participants 32 participants
NA [2]   (NA) 40.3  (19.2)
Cycle 14 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
3.97  (1.14)
Cycle 14 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
44.5  (7.05)
Cycle 15 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
4.02  (1.40)
Cycle 15 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
49.7  (6.88)
Cycle 16 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
4.60  (1.67)
Cycle 16 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
49.7  (7.61)
[1]
Data was below the limit of quantification.
[2]
No participant was analyzed in this arm group at this time point.
21.Secondary Outcome
Title Monomethyl Auristatin E (MMAE) Plasma Concentrations (Phase 1 and 2)
Hide Description Blood samples were collected and tested for MMAE plasma concentrations.
Time Frame Cycle 1 and 8 pre-dose and 5 minutes, 24, 48, 96 and 312 hours post-dose; Cycle 2 pre-dose, 5 minutes and 24, 48 and 96 hours post-dose; Cycle 3 to 16 pre-dose and 5 minutes post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK-evaluable population was defined as participants with sufficient dosing and PK data to reliably estimate PK parameters. Cycle 2 Day 2 values are collected in phase 1 participants only. Here, number analyzed is number of participants assessed at given time-point. Data summarized together for all participants in brentuximab vedotin 1.8 mg/kg arm.
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1
Hide Arm/Group Description:
Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
Overall Number of Participants Analyzed 3 33
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 1, Pre-Dose Number Analyzed 2 participants 32 participants
NA [1]   (NA) NA [1]   (NA)
Cycle 1 Day 1, 5 Minutes Post-Dose Number Analyzed 3 participants 32 participants
0.416  (0.480) 0.368  (0.309)
Cycle 1 Day 2, 24 Hours Post-Dose Number Analyzed 3 participants 32 participants
4.63  (3.20) 4.88  (3.55)
Cycle 1 Day 3, 48 Hours Post-Dose Number Analyzed 3 participants 32 participants
4.20  (1.95) 5.36  (3.72)
Cycle 1 Day 5, 96 Hours Post-Dose Number Analyzed 3 participants 32 participants
2.80  (0.300) 4.43  (3.04)
Cycle 1 Day 14, 312 Hours Post-Dose Number Analyzed 3 participants 31 participants
0.196  (0.0641) 0.530  (0.552)
Cycle 2 Day 1, Pre-Dose Number Analyzed 3 participants 29 participants
0.0647  (0.0358) 0.0739  (0.0640)
Cycle 2 Day 1, 5-minutes Post-Dose Number Analyzed 3 participants 29 participants
0.556  (0.562) 0.478  (0.461)
Cycle 2 Day 2, 24 Hours Post-Dose Number Analyzed 3 participants 8 participants
5.63  (5.72) 3.71  (3.94)
Cycle 2 Day 3, 48 Hours Post-Dose Number Analyzed 3 participants 30 participants
4.60  (3.70) 3.86  (3.18)
Cycle 2 Day 5, 96 Hours Post-Dose Number Analyzed 3 participants 29 participants
2.60  (1.04) 2.70  (1.69)
Cycle 3 Day 1, Pre-Dose Number Analyzed 2 participants 26 participants
0.0250  (0.0354) 0.0650  (0.0590)
Cycle 3 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 25 participants
0.216  (0.0361) 0.514  (0.684)
Cycle 4 Day 1, Pre-dose Number Analyzed 2 participants 19 participants
0.0565  (0.00495) 0.0866  (0.0784)
Cycle 4 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 19 participants
0.234  (0.0742) 0.376  (0.449)
Cycle 5 Day 1, Pre-Dose Number Analyzed 2 participants 18 participants
0.0820 [2]   (NA) 0.0862  (0.0729)
Cycle 5 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 18 participants
0.334  (0.0955) 0.301  (0.248)
Cycle 6 Day 1, Pre-Dose Number Analyzed 2 participants 15 participants
0.0680  (0.0156) 0.0841  (0.0632)
Cycle 6 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 15 participants
0.247  (0.00707) 0.450  (0.663)
Cycle 7 Day 1, Pre-Dose Number Analyzed 2 participants 16 participants
0.104  (0.0389) 0.0830  (0.0578)
Cycle 7 Day 1, 5 minutes Post-Dose Number Analyzed 2 participants 15 participants
0.326  (0.0361) 0.310  (0.282)
Cycle 8 Day 1, Pre-Dose Number Analyzed 0 participants 13 participants
0.101  (0.934)
Cycle 8 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 12 participants
0.295  (0.151)
Cycle 8 Day 2, 24 Hours Post-Dose Number Analyzed 0 participants 13 participants
1.96  (1.31)
Cycle 8 Day 3, 48 Hours Post-Dose Number Analyzed 0 participants 13 participants
1.91  (1.29)
Cycle 8 Day 5, 96 Hours Post-Dose Number Analyzed 0 participants 13 participants
2.00  (1.05)
Cycle 8 Day 14, 312 Hours Post-Dose Number Analyzed 0 participants 12 participants
0.325  (0.214)
Cycle 9 Day 1, Pre-Dose Number Analyzed 0 participants 13 participants
0.0819  (0.0496)
Cycle 9 Day 1, 5 Minutes Post-Dose Number Analyzed 0 participants 12 participants
0.218  (0.128)
Cycle 10 Day 1, Pre-Dose Number Analyzed 0 participants 12 participants
0.727  (0.0517)
Cycle 10 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 12 participants
0.204  (0.0982)
Cycle 11 Day 1, Pre-Dose Number Analyzed 0 participants 7 participants
0.0763  (0.0368)
Cycle 11 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 7 participants
0.255  (0.133)
Cycle 12 Day 1, Pre-Dose Number Analyzed 0 participants 5 participants
0.105  (0.0983)
Cycle 12 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 5 participants
0.252  (0.116)
Cycle 13 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
0.110  (0.0629)
Cycle 13 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
0.244  (0.130)
Cycle 14 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
0.109  (0.0529)
Cycle 14 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
0.320  (0.138)
Cycle 15 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
0.0843  (0.0548)
Cycle 15 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
0.404  (0.192)
Cycle 16 Day 1, Pre-Dose Number Analyzed 0 participants 6 participants
0.139  (0.0926)
Cycle 16 Day 1, 5 minutes Post-Dose Number Analyzed 0 participants 6 participants
0.381  (0.277)
[1]
Data was below the limit of quantification.
[2]
Standard deviation was not estimable for 2 participants.
Time Frame From the first dose through 30 days after the last dose of study medication (Up to 15 months)
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. At the time of study completion, a total of 9 deaths were reported for the safety population, 1 on study death (death within 30 days of last dose) and 8 deaths during post-treatment follow up (PTFU).
 
Arm/Group Title Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Hide Arm/Group Description Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity. Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit. Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
All-Cause Mortality
Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/3 (33.33%)   6/16 (37.50%)   2/17 (11.76%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)   7/16 (43.75%)   1/17 (5.88%) 
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Cardiac disorders       
Supraventricular tachycardia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Cardiac arrest  1 [1]  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Gastrointestinal disorders       
Vomiting  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
General disorders       
Pyrexia  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Myalgia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Hepatobiliary disorders       
Hepatotoxicity  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Immune system disorders       
Anaphylactic reaction  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Infections and infestations       
Pneumonia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
1
Term from vocabulary, MedDRA v 19.0
Indicates events were collected by systematic assessment
[1]
One treatment-emergent death occurred during treatment with brentuximab 1.8 mg/kg and was not related.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brentuximab Vedotin 1.4 mg/kg: Phase 1 Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   3/3 (100.00%)   16/16 (100.00%)   17/17 (100.00%) 
Blood and lymphatic system disorders       
Neutropenia  1  0/3 (0.00%)  4/16 (25.00%)  1/17 (5.88%) 
Lymph node pain  1  0/3 (0.00%)  2/16 (12.50%)  1/17 (5.88%) 
Lymphadenopathy  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Anaemia  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Leukopenia  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Thrombocytopenia  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Cardiac disorders       
Angina pectoris  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Sinus tachycardia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Ear and labyrinth disorders       
Tinnitus  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Eye disorders       
Eye discharge  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Gastrointestinal disorders       
Nausea  1  2/3 (66.67%)  7/16 (43.75%)  4/17 (23.53%) 
Vomiting  1  0/3 (0.00%)  2/16 (12.50%)  3/17 (17.65%) 
Abdominal pain upper  1  1/3 (33.33%)  2/16 (12.50%)  1/17 (5.88%) 
Abdominal pain  1  1/3 (33.33%)  2/16 (12.50%)  0/17 (0.00%) 
Gastrointestinal pain  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Diarrhoea  1  0/3 (0.00%)  2/16 (12.50%)  3/17 (17.65%) 
Constipation  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Gastrooesophageal reflux disease  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Gastritis  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Toothache  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Dyspepsia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Gastrointestinal motility disorder  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Dysphagia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Odynophagia  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
General disorders       
Pyrexia  1  1/3 (33.33%)  8/16 (50.00%)  7/17 (41.18%) 
Fatigue  1  0/3 (0.00%)  2/16 (12.50%)  1/17 (5.88%) 
Asthenia  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Feeling hot  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Oedema peripheral  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Hepatobiliary disorders       
Hepatotoxicity  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Hypertransaminasaemia  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Hepatic pain  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Infections and infestations       
Rhinitis  1  0/3 (0.00%)  3/16 (18.75%)  4/17 (23.53%) 
Pharyngitis  1  0/3 (0.00%)  3/16 (18.75%)  3/17 (17.65%) 
Nasopharyngitis  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Sinusitis  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Upper respiratory tract infection  1  1/3 (33.33%)  0/16 (0.00%)  0/17 (0.00%) 
Gingivitis  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Tooth abscess  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Clostridium difficile colitis  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Conjunctivitis  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Vulvovaginal mycotic infection  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Herpes zoster  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Influenza  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Respiratory syncytial virus infection  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Paronychia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Injury, poisoning and procedural complications       
Joint dislocation  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Muscle strain  1  1/3 (33.33%)  0/16 (0.00%)  0/17 (0.00%) 
Head injury  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Facial bones fracture  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Investigations       
Gamma-glutamyltransferase increased  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Alanine aminotransferase increased  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Aspartate aminotransferase increased  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Transaminases increased  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Lymphocyte count decreased  1  1/3 (33.33%)  0/16 (0.00%)  2/17 (11.76%) 
Neutrophil count decreased  1  0/3 (0.00%)  0/16 (0.00%)  2/17 (11.76%) 
White blood cell count decreased  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Blood bicarbonate decreased  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Weight decreased  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
C-reactive protein increased  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Blood alkaline phosphatase increased  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Metabolism and nutrition disorders       
Decreased appetite  1  0/3 (0.00%)  3/16 (18.75%)  0/17 (0.00%) 
Hypokalaemia  1  0/3 (0.00%)  2/16 (12.50%)  1/17 (5.88%) 
Hyperuricaemia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Hypophosphataemia  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Hypoalbuminaemia  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Musculoskeletal and connective tissue disorders       
Pain in extremity  1  0/3 (0.00%)  2/16 (12.50%)  1/17 (5.88%) 
Musculoskeletal pain  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Back pain  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Neck pain  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Myalgia  1  0/3 (0.00%)  4/16 (25.00%)  0/17 (0.00%) 
Arthralgia  1  1/3 (33.33%)  1/16 (6.25%)  0/17 (0.00%) 
Muscle spasms  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Groin pain  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Cancer pain  1  1/3 (33.33%)  0/16 (0.00%)  0/17 (0.00%) 
Nervous system disorders       
Paraesthesia  1  1/3 (33.33%)  5/16 (31.25%)  1/17 (5.88%) 
Peripheral sensory neuropathy  1  0/3 (0.00%)  2/16 (12.50%)  2/17 (11.76%) 
Neuropathy peripheral  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Peripheral motor neuropathy  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Headache  1  0/3 (0.00%)  0/16 (0.00%)  3/17 (17.65%) 
Migraine  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Dysgeusia  1  1/3 (33.33%)  0/16 (0.00%)  0/17 (0.00%) 
Tremor  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Vocal cord paralysis  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Psychiatric disorders       
Insomnia  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Anxiety  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Renal and urinary disorders       
Pollakiuria  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Urinary tract pain  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Reproductive system and breast disorders       
Menstruation irregular  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/3 (0.00%)  3/16 (18.75%)  1/17 (5.88%) 
Oropharyngeal pain  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Dyspnoea  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Skin and subcutaneous tissue disorders       
Rash  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Rash maculo-papular  1  0/3 (0.00%)  0/16 (0.00%)  2/17 (11.76%) 
Blister  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Dermatosis  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Dry skin  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Pruritus  1  0/3 (0.00%)  2/16 (12.50%)  0/17 (0.00%) 
Urticaria  1  0/3 (0.00%)  1/16 (6.25%)  1/17 (5.88%) 
Alopecia  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Night sweats  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Seborrhoeic dermatitis  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Drug eruption  1  1/3 (33.33%)  0/16 (0.00%)  0/17 (0.00%) 
Erythema  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
Erythema multiforme  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Vascular disorders       
Haematoma  1  0/3 (0.00%)  1/16 (6.25%)  0/17 (0.00%) 
Flushing  1  0/3 (0.00%)  0/16 (0.00%)  1/17 (5.88%) 
1
Term from vocabulary, MedDRA v 19.0
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.
In general, Investigators may publish clinical data after the earlier of (i) publication by the Sponsor or (ii) 12 months following the abandonment, early termination or database lock; provided a copy of the publication provided to Sponsor at least 30 days ahead of publication, the Sponsor’s confidential information is removed as may be requested by Sponsor and Investigator defers publication for up to 60 days in the event Sponsor provides notice that it intends to file a patent application.
Results Point of Contact
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Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
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Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01492088     History of Changes
Other Study ID Numbers: C25002
2011-001240-29 ( EudraCT Number )
U1111-1158-2613 ( Registry Identifier: WHO )
133300410A0384 ( Registry Identifier: RNEC )
NL38209.078.11 ( Registry Identifier: CCMO )
First Submitted: December 12, 2011
First Posted: December 14, 2011
Results First Submitted: April 5, 2017
Results First Posted: May 15, 2017
Last Update Posted: November 20, 2018