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A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study) (ALCANZA)

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ClinicalTrials.gov Identifier: NCT01578499
Recruitment Status : Completed
First Posted : April 17, 2012
Results First Posted : March 16, 2018
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Takeda ( Millennium Pharmaceuticals, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Primary Cutaneous Anaplastic Large Cell Lymphoma
Mycosis Fungoides
Cutaneous T-Cell Lymphoma
Interventions Drug: Brentuximab Vedotin
Drug: Methotrexate
Drug: Bexarotene
Enrollment 131
Recruitment Details Participants took part in the study at 34 investigative sites in Australia, Belgium, Brazil, France, Germany, Italy, Poland, Spain, Switzerland, United Kingdom, United States from 11 June 2012 to the Primary Completion data of 06 July 2018.
Pre-assignment Details Participants with a diagnosis of cluster of differentiation antigen 30 (CD30)-Positive Cutaneous T-Cell Lymphoma were enrolled equally in 1 of 2 arms: brentuximab vedotin 1.8 mg/kg or physician’s choice (Methotrexate or Bexarotene).
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks). Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Period Title: Overall Study
Started 66 65
Safety Population: Treated 66 62
Intent to Treat Population: CD30+ 64 64
Completed 32 22
Not Completed 34 43
Reason Not Completed
Reason not Specified             0             1
Lost to Follow-up             2             1
Withdrawal by Subject             10             16
Death             20             25
Died and End of Study Page not Completed             2             0
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene Total
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks). Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks. Total of all reporting groups
Overall Number of Baseline Participants 66 64 130
Hide Baseline Analysis Population Description
Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received (n=66,62). Intent-to-treat population (ITT) population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment (n=64,64).
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 66 participants 62 participants 128 participants
59.4  (13.80) 56.6  (14.43) 58.0  (14.12)
[1]
Measure Analysis Population Description: Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 66 participants 62 participants 128 participants
Female
33
  50.0%
28
  45.2%
61
  47.7%
Male
33
  50.0%
34
  54.8%
67
  52.3%
[1]
Measure Analysis Population Description: Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 64 participants 64 participants 128 participants
56 53 109
Black or African American Number Analyzed 64 participants 64 participants 128 participants
3 3 6
Asian Number Analyzed 64 participants 64 participants 128 participants
1 5 6
Not reported Number Analyzed 64 participants 64 participants 128 participants
3 1 4
Other Number Analyzed 64 participants 64 participants 128 participants
1 2 3
[1]
Measure Analysis Population Description: ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Hispanic or Latino Number Analyzed 64 participants 64 participants 128 participants
2 6 8
Not Hispanic or Latino Number Analyzed 64 participants 64 participants 128 participants
60 50 110
Not reported Number Analyzed 64 participants 64 participants 128 participants
2 8 10
[1]
Measure Analysis Population Description: ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Region of Enrollment   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Australia Number Analyzed 66 participants 62 participants 128 participants
12
  18.2%
8
  12.9%
20
  15.6%
Belgium Number Analyzed 66 participants 62 participants 128 participants
4
   6.1%
2
   3.2%
6
   4.7%
France Number Analyzed 66 participants 62 participants 128 participants
4
   6.1%
3
   4.8%
7
   5.5%
Germany Number Analyzed 66 participants 62 participants 128 participants
3
   4.5%
2
   3.2%
5
   3.9%
Italy Number Analyzed 66 participants 62 participants 128 participants
12
  18.2%
6
   9.7%
18
  14.1%
Poland Number Analyzed 66 participants 62 participants 128 participants
2
   3.0%
1
   1.6%
3
   2.3%
Spain Number Analyzed 66 participants 62 participants 128 participants
2
   3.0%
3
   4.8%
5
   3.9%
Switzerland Number Analyzed 66 participants 62 participants 128 participants
3
   4.5%
3
   4.8%
6
   4.7%
United Kingdom Number Analyzed 66 participants 62 participants 128 participants
8
  12.1%
15
  24.2%
23
  18.0%
United States Number Analyzed 66 participants 62 participants 128 participants
14
  21.2%
17
  27.4%
31
  24.2%
Brazil Number Analyzed 66 participants 62 participants 128 participants
2
   3.0%
2
   3.2%
4
   3.1%
[1]
Measure Analysis Population Description: Safety population included participants who received at least 1 dose of study drug, analyzed according to the actual treatment received.
1.Primary Outcome
Title Percentage of Participants Achieving an Objective Response That Lasts at Least 4 Months (ORR4)
Hide Description ORR4 was determined by an Independent Review Facility (IRF) based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic assessment by an IRF and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Participants whose first response occurred after the start of subsequent anticancer therapy were excluded. Response Criteria was based on International Society for Cutaneous Lymphomas (ISCL), United States Cutaneous Lymphoma Consortium (USCLC) and Cutaneous Lymphoma Task Force (CLTF) of the European Organisation for Research and Treatment of Cancer (EORTC) Consensus guidelines (Olsen, 2011).
Time Frame Each Cycle until disease progression, death End of treatment (Median overall follow-up 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
54.7
(42.5 to 66.9)
12.5
(4.4 to 20.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brentuximab Vedotin, Methotrexate or Bexarotene
Comments Based on a two-sided Χ² test with a significance level of 0.05, and a 10% dropout rate, a sample size of approximately 124 participants was calculated to provide 90% power to detect a 30% improvement in ORR4 in the brentuximab vedotin group.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value was stratified by baseline disease diagnosis (pcALCL and MF).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 42.2
Confidence Interval (2-Sided) 95%
27.5 to 56.8
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Participants Achieving a CR
Hide Description Complete Response (CR) was determined by the IRF based on Global Response Score (GRS) which consisted of a skin assessment by the investigator using the modified severity-weighted assessment tool (mSWAT), nodal and visceral radiographic and for the participants with mycosis fungoides (MF) only, detection of circulation Sezary cells. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame Each Cycle until disease progression, death or data cutoff (Median overall follow-up 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 64 64
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17.2
(7.9 to 26.4)
1.6
(0.0 to 8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brentuximab Vedotin, Methotrexate or Bexarotene
Comments [Not Specified]
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments P-value was stratified by baseline disease diagnosis (pcALCL and MF).
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 15.6
Confidence Interval (2-Sided) 95%
-2.5 to 33.0
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-Free Survival (PFS)
Hide Description PFS was assessed by the IRF and is defined as the time from randomization until disease progression or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame Until disease progression, death or data cutoff (Median PFS follow-up of 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 64 64
Median (95% Confidence Interval)
Unit of Measure: months
16.7
(15.4 to 21.6)
3.5
(2.4 to 4.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brentuximab Vedotin, Methotrexate or Bexarotene
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.378
Confidence Interval (2-Sided) 95%
0.247 to 0.577
Estimation Comments [Not Specified]
Other Statistical Analysis Hazard ratio brentuximab vedotin/ comparator (methotrexate or bexarotene) with the 95% CI from a stratified Cox regression model with treatment as the explanatory variable and baseline disease diagnosis (MF or pcALCL) as stratification factor.
4.Secondary Outcome
Title Maximum Change From Baseline in Symptom Domain Score of the Skindex-29 Questionnaire
Hide Description Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, from 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
Time Frame Baseline up to End of Treatment (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here number of participants analyzed are participants evaluable for this outcome measure.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 58 54
Mean (Standard Deviation)
Unit of Measure: score on a scale
-28.08  (26.863) -8.62  (17.013)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Brentuximab Vedotin, Methotrexate or Bexarotene
Comments P-value is calculated using the analysis of covariance (ANCOVA) model controlling for baseline symptom domain score, eastern cooperative oncology group (ECOG) performance status score (=0 and ≥1), and disease diagnosis (pcALCL and MF) between the brentuximab vedotin and comparator (methotrexate or bexarotene) arms.
Type of Statistical Test Superiority or Other (legacy)
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Estimate of difference
Estimated Value -19.0
Confidence Interval (2-Sided) 95%
-26.7 to -11.4
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Duration of Response (DOR)
Hide Description Duration of response was assessed by the IRF in participants with confirmed response [CR or Partial Response (PR)] and is defined as the time between first documentation of response and disease progression. Response Criteria was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame Until disease progression, death or data cutoff (Median follow-up 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Responders in ITT population were analyzed in this outcome measure.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 42 13
Median (95% Confidence Interval)
Unit of Measure: months
15.1
(9.8 to 25.5)
18.4 [1] 
(3.5 to NA)
[1]
Upper limit of Confidence Interval (CI) was not estimable due to low number of participants with events.
6.Secondary Outcome
Title DOR of Skin Response
Hide Description Duration of skin response (CR and PR) was assessed by the investigator and is defined as the time between the first skin response to progressive disease in skin. Per mSWAT, CR is defined as 100% clearance of skin lesions. PR is defined as 50%-99% clearance of skin disease from Baseline; No new tumors in participants without tumors at Baseline -MF; No new tumors-primary cutaneous anaplastic large cell lymphoma (pcALCL).Progressive disease is defined as ≥ 25% increase in skin disease from baseline, or loss of response: in those with CR or PR, increase of skin score of greater than the sum of nadir plus 50% baseline score, or new tumors in participants without tumors at baseline (MF).
Time Frame Until disease progression, death or data cutoff (Median follow-up 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Skin responders in ITT population were analyzed in this outcome measure.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 47 19
Median (95% Confidence Interval)
Unit of Measure: months
18.9
(15.0 to 25.7)
18.3 [1] 
(3.5 to NA)
[1]
Upper limit of Confidence Interval (CI) was not estimable due to low number of participants with events.
7.Secondary Outcome
Title Event-Free Survival (EFS)
Hide Description EFS was assessed by the IRF and is defined as the time from randomization until any cause of treatment failure: disease progression, discontinuation of treatment for any reason, or death due to any cause, whichever occurs first. Disease progression was based on ISCL, USCLC and CLTF of the EORTC Consensus guidelines (Olsen, 2011).
Time Frame From randomization until disease progression, death or data cutoff (Median follow-up 36.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 64 64
Median (95% Confidence Interval)
Unit of Measure: months
9.4
(5.9 to 11.7)
2.3
(1.7 to 3.5)
8.Secondary Outcome
Title Cmax: Maximum Observed Concentration for Brentuximab Vedotin
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and 30 minutes after infusion in Cycles 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Arm/Group Title pcALCL: Brentuximab Vedotin MF: Brentuximab Vedotin 1.8 mg/kg
Hide Arm/Group Description:
Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Participants with mycosis fungoides (MF) received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed 16 50
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 1 Day 1 Number Analyzed 15 participants 50 participants
38.36  (9.427) 38.40  (8.912)
Cycle 3 Day 1 Number Analyzed 12 participants 41 participants
40.14  (12.697) 36.69  (14.249)
9.Secondary Outcome
Title Ctrough: Observed Concentration at the End of a Dosing Interval for Brentuximab Vedotin
Hide Description [Not Specified]
Time Frame Day 1 pre-dose of Cycles 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Arm/Group Title pcALCL: Brentuximab Vedotin MF: Brentuximab Vedotin 1.8 mg/kg
Hide Arm/Group Description:
Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed 16 50
Mean (Standard Deviation)
Unit of Measure: ug/mL
Cycle 2 Day 1 Number Analyzed 11 participants 31 participants
3.57  (10.101) 0.58  (0.517)
Cycle 4 Day 1 Number Analyzed 8 participants 28 participants
0.99  (0.528) 0.78  (0.446)
10.Secondary Outcome
Title Cmax: Maximum Observed Concentration for Monomethyl Auristatin (MMAE) for Brentuximab Vedotin
Hide Description [Not Specified]
Time Frame Day 1 pre-dose and 30 minutes after infusion ended in Cycles 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Arm/Group Title pcALCL: Brentuximab Vedotin MF: Brentuximab Vedotin 1.8 mg/kg
Hide Arm/Group Description:
Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed 16 50
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1 Day 1 Number Analyzed 13 participants 46 participants
2.53  (1.382) 3.34  (1.901)
Cycle 3 Day 1 Number Analyzed 12 participants 36 participants
2.96  (1.176) 3.08  (1.276)
11.Secondary Outcome
Title Ctrough: Observed Concentration at the End of a Dosing Interval for MMAE for Brentuximab Vedotin
Hide Description [Not Specified]
Time Frame Day 1 pre-dose of Cycles 2 and 4
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population included participants with sufficient dose and PK data to reliably estimate PK parameters as determined by a clinical pharmacologist. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Arm/Group Title pcALCL: Brentuximab Vedotin MF: Brentuximab Vedotin 1.8 mg/kg
Hide Arm/Group Description:
Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed 16 50
Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 2 Day 1 Number Analyzed 11 participants 33 participants
0.11  (0.095) 0.09  (0.060)
Cycle 4 Day 1 Number Analyzed 10 participants 34 participants
0.14  (0.113) 0.11  (0.091)
12.Secondary Outcome
Title Number of Participants With Antitherapeutic Antibodies (ATA) to Brentuximab Vedotin
Hide Description Blood was collected and evaluated for ATA and neutralizing ATA in all participants who received brentuximab vedotin to assess immunogenicity.
Time Frame Baseline up to End of Treatment (Week 52)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included participants who received at least one dose of study drug.
Arm/Group Title pcALCL: Brentuximab Vedotin MF: Brentuximab Vedotin 1.8 mg/kg
Hide Arm/Group Description:
Participants with pcALCL received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Participants with MF received brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Overall Number of Participants Analyzed 16 50
Measure Type: Number
Unit of Measure: participants
Immunogenicity-evaluable participants 14 46
Baseline Negative: ATA negative 8 23
Baseline Negative: ATA positive 6 19
Baseline Negative: Transiently Positive 4 9
Baseline Negative: Persistently Positive 2 10
Baseline Negative: Neutralizing ATA Positive 4 14
Baseline Positive: ATA Negative 0 1
Baseline Positive: ATA Positive 0 3
Baseline Positive: Transiently Positive 0 3
Baseline Positive: Persistently Positive 0 0
Baseline Positive: Neutralizing ATA Positive 0 2
13.Secondary Outcome
Title Change From Baseline in the Skindex-29 Questionnaire Total Score
Hide Description Skindex-29 is a 29-item dermatology-specific health-related quality of life (HRQoL). The Skindex-29 incorporates a 28-day recall period and consists of 3 domains: symptoms, emotions, and functioning. The domain scores and an overall score are expressed on a 100-point scale, 0 to 100 with higher scores indicating lower levels of health- HRQoL. A negative change (reduction) from Baseline indicates improvement.
Time Frame Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at End of Treatment (EOT) and during posttreatment long treatment follow-up (LTFU) - (Median follow-up 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 64 64
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Cycle 2 Number Analyzed 55 participants 45 participants
-5.44  (11.055) -2.49  (11.959)
Change at Cycle 4 Number Analyzed 49 participants 30 participants
-14.60  (17.488) -6.71  (9.755)
Change at Cycle 6 Number Analyzed 40 participants 25 participants
-17.59  (17.770) -5.40  (9.758)
Change at Cycle 8 Number Analyzed 37 participants 14 participants
-21.73  (18.882) -7.28  (16.769)
Change at Cycle 10 Number Analyzed 35 participants 13 participants
-22.47  (21.722) -3.71  (21.752)
Change at Cycle 12 Number Analyzed 25 participants 8 participants
-23.37  (21.555) -5.22  (17.704)
Change at Cycle 14 Number Analyzed 25 participants 5 participants
-19.72  (20.980) -7.49  (22.463)
Change at Cycle 16 Number Analyzed 22 participants 3 participants
-19.35  (18.911) 0.75  (10.308)
Change at End of Treatment Number Analyzed 47 participants 37 participants
-16.26  (23.281) -0.96  (18.973)
Change at 3-6 months LTFU Number Analyzed 2 participants 3 participants
-1.07  (3.704) -9.48  (21.629)
Change at 6-9 months LTFU Number Analyzed 6 participants 11 participants
-8.04  (8.800) -9.68  (17.789)
Change at 9-12 months LTFU Number Analyzed 7 participants 10 participants
-7.94  (15.582) -4.93  (14.516)
Change at 12-15 months LTFU Number Analyzed 25 participants 21 participants
-16.21  (18.438) -11.16  (18.183)
Change at 15-18 months LTFU Number Analyzed 25 participants 18 participants
-19.18  (19.475) -8.53  (12.768)
Change at 18-21 months LTFU Number Analyzed 22 participants 17 participants
-19.27  (20.962) -5.46  (16.679)
Change at 21-24 months LTFU Number Analyzed 18 participants 19 participants
-16.60  (19.875) -6.86  (14.991)
Change at 24-27 months LTFU Number Analyzed 21 participants 16 participants
-17.04  (15.982) -9.05  (23.990)
Change at 27-30 months LTFU Number Analyzed 20 participants 18 participants
-12.45  (19.639) -7.97  (16.401)
Change at >30 months LTFU Number Analyzed 23 participants 20 participants
-11.49  (22.470) -1.07  (18.886)
14.Secondary Outcome
Title Change From Baseline in Functional Assessment of Cancer Therapy General Questionnaire (FACT-G) Score
Hide Description FACT-G is a 27-item general cancer QOL instrument completed by participants receiving cancer treatment. FACT-G incorporates a 7-day recall period and contains 4 primary subscales: Physical Well-Being (PWB; sum of 7 items, point range 0-28); Social/Family Well-Being (SWB, sum of 7-items, point range 0-28); Emotional Well-Being (EWB; sum of 6-items, point range 0-24); Functional Well-Being (FWB; sum of 7-items, point range 0-28); Fact-G total score=sum of PWB, SWB, EWB, FWB, point range 0-108. Higher scores for the total scales and subscales indicate better quality of life. A negative change (reduction) from Baseline indicates improvement.
Time Frame Day 1 of Cycles 1, 2, 4, 6, 8, 10, 12, 14, 16, at EOT and during posttreatment (LTFU) - (Median follow-up 38.8 months)
Hide Outcome Measure Data
Hide Analysis Population Description
The ITT population included all participants who were identified as CD30+ by the Ventana anti-CD30 (Ber-H2) assay and were randomized to treatment. Here 'Number analyzed' is the number of participants with evaluable data at the specified time-point.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 64 64
Mean (Standard Deviation)
Unit of Measure: score on a scale
Change at Cycle 2 Number Analyzed 56 participants 46 participants
1.43  (10.168) -0.37  (11.723)
Change at Cycle 4 Number Analyzed 50 participants 32 participants
1.75  (12.014) 1.78  (10.740)
Change at Cycle 6 Number Analyzed 40 participants 25 participants
4.23  (14.257) 2.24  (13.108)
Change at Cycle 8 Number Analyzed 37 participants 13 participants
5.96  (16.030) 2.54  (10.809)
Change at Cycle 10 Number Analyzed 35 participants 13 participants
6.61  (16.971) 4.38  (15.040)
Change at Cycle 12 Number Analyzed 27 participants 8 participants
7.94  (18.837) 8.61  (21.024)
Change at Cycle 14 Number Analyzed 26 participants 6 participants
9.04  (14.104) 10.75  (13.615)
Change at Cycle 16 Number Analyzed 22 participants 4 participants
5.08  (9.230) 7.88  (23.432)
Change at End of Treatment Number Analyzed 47 participants 37 participants
0.35  (16.067) -2.29  (17.171)
Change at 3-6 months LTFU Number Analyzed 2 participants 2 participants
16.00  (18.385) -2.92  (8.367)
Change at 6-9 months LTFU Number Analyzed 6 participants 12 participants
-0.19  (19.648) -2.59  (12.473)
Change at 9-12 months LTFU Number Analyzed 7 participants 10 participants
3.62  (17.651) -5.32  (10.555)
Change at 12-15 months LTFU Number Analyzed 26 participants 19 participants
8.33  (14.918) -1.34  (11.905)
Change at 15-18 months LTFU Number Analyzed 24 participants 18 participants
3.03  (12.618) 2.94  (14.756)
Change at 18-21 months LTFU Number Analyzed 24 participants 16 participants
3.35  (11.117) -0.19  (14.316)
Change at 21-24 months LTFU Number Analyzed 17 participants 18 participants
1.51  (5.471) 0.61  (14.505)
Change at 24-27 months LTFU Number Analyzed 20 participants 15 participants
4.20  (7.952) 1.42  (17.870)
Change at 27-30 months LTFU Number Analyzed 19 participants 17 participants
-1.57  (17.488) 1.93  (8.716)
Change at >30 months LTFU Number Analyzed 22 participants 19 participants
-6.22  (15.222) -2.85  (5.518)
15.Secondary Outcome
Title Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Hide Description AEs and SAEs were assessed according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03. 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 SAE is any AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of an existing hospitalization, results in significant disability or incapacity, is a congenital anomaly/birth defect or is a medically important event.
Time Frame First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included participants who received at least one dose of study drug.
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks).
Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
Overall Number of Participants Analyzed 66 62
Measure Type: Number
Unit of Measure: participants
AEs 63 56
SAEs 18 18
Time Frame All-Cause mortality: Baseline up to End of study (Up to 6 years); Serious and Other adverse events: First dose of study drug through 30 days after last dose of study drug (Up to 450 days)
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.
 
Arm/Group Title Brentuximab Vedotin Methotrexate or Bexarotene
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg, intravenous over approximately 30 minutes, once on Day 1 of each 21-day cycle and may continue as monotherapy for up to a total of 16 cycles (48 weeks). Methotrexate 5 to 50 mg, tablets, orally, once weekly (dose adjustment is guided by patient response and toxicity) or Bexarotene 300 mg/m^2, tablets, orally, once daily with meals for up to 48 weeks.
All-Cause Mortality
Brentuximab Vedotin Methotrexate or Bexarotene
Affected / at Risk (%) Affected / at Risk (%)
Total   22/66 (33.33%)   25/62 (40.32%) 
Show Serious Adverse Events Hide Serious Adverse Events
Brentuximab Vedotin Methotrexate or Bexarotene
Affected / at Risk (%) Affected / at Risk (%)
Total   18/66 (27.27%)   18/62 (29.03%) 
Blood and lymphatic system disorders     
Haemolytic uraemic syndrome  1  1/66 (1.52%)  0/62 (0.00%) 
Gastrointestinal disorders     
Pancreatitis  1  1/66 (1.52%)  0/62 (0.00%) 
Diarrhoea  1  1/66 (1.52%)  0/62 (0.00%) 
Intestinal perforation  1  1/66 (1.52%)  0/62 (0.00%) 
General disorders     
Pyrexia  1  2/66 (3.03%)  4/62 (6.45%) 
Extravasation  1  1/66 (1.52%)  0/62 (0.00%) 
General physical health deterioration  1  1/66 (1.52%)  0/62 (0.00%) 
Multiple organ dysfunction syndrome  1 [1]  1/66 (1.52%)  0/62 (0.00%) 
Fatigue  1  1/66 (1.52%)  0/62 (0.00%) 
Hepatobiliary disorders     
Hepatocellular injury  1  1/66 (1.52%)  0/62 (0.00%) 
Infections and infestations     
Cellulitis  1  2/66 (3.03%)  0/62 (0.00%) 
Superinfection bacterial  1  0/66 (0.00%)  1/62 (1.61%) 
Diverticulitis  1  1/66 (1.52%)  0/62 (0.00%) 
Lower respiratory tract infection  1  1/66 (1.52%)  0/62 (0.00%) 
Sepsis  1 [2]  1/66 (1.52%)  3/62 (4.84%) 
Urosepsis  1  0/66 (0.00%)  1/62 (1.61%) 
Impetigo  1  1/66 (1.52%)  0/62 (0.00%) 
Sinusitis  1  1/66 (1.52%)  0/62 (0.00%) 
Urinary tract infection  1  1/66 (1.52%)  0/62 (0.00%) 
Parotitis  1  0/66 (0.00%)  1/62 (1.61%) 
Periorbital infection  1  0/66 (0.00%)  1/62 (1.61%) 
Erysipelas  1  0/66 (0.00%)  1/62 (1.61%) 
Skin infection  1  0/66 (0.00%)  1/62 (1.61%) 
Injury, poisoning and procedural complications     
Fracture  1  1/66 (1.52%)  0/62 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/66 (1.52%)  0/62 (0.00%) 
Hypernatraemia  1  0/66 (0.00%)  1/62 (1.61%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal chest pain  1  1/66 (1.52%)  0/62 (0.00%) 
Neck pain  1  1/66 (1.52%)  0/62 (0.00%) 
Crystal arthropathy  1  0/66 (0.00%)  1/62 (1.61%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Lymphoma  1 [3]  1/66 (1.52%)  0/62 (0.00%) 
Squamous cell carcinoma of skin  1  0/66 (0.00%)  1/62 (1.61%) 
Nervous system disorders     
Dizziness  1  1/66 (1.52%)  0/62 (0.00%) 
Neuropathy peripheral  1  1/66 (1.52%)  0/62 (0.00%) 
Neuralgia  1  0/66 (0.00%)  1/62 (1.61%) 
Psychiatric disorders     
Stress  1  1/66 (1.52%)  0/62 (0.00%) 
Renal and urinary disorders     
Urinary retention  1  1/66 (1.52%)  0/62 (0.00%) 
Haematuria  1  0/66 (0.00%)  1/62 (1.61%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism  1 [4]  1/66 (1.52%)  0/62 (0.00%) 
Skin and subcutaneous tissue disorders     
Drug eruption  1  1/66 (1.52%)  0/62 (0.00%) 
Rash maculo-papular  1  1/66 (1.52%)  0/62 (0.00%) 
Dermatitis bullous  1  0/66 (0.00%)  1/62 (1.61%) 
Skin erosion  1  0/66 (0.00%)  1/62 (1.61%) 
Vascular disorders     
Hypotension  1  1/66 (1.52%)  0/62 (0.00%) 
Peripheral vascular disorder  1  0/66 (0.00%)  1/62 (1.61%) 
Peripheral ischaemia  1  0/66 (0.00%)  1/62 (1.61%) 
1
Term from vocabulary, MedDRA 21.0
Indicates events were collected by systematic assessment
[1]
One treatment-emergent death occurred in participant with pcALCL during treatment with brentuximab vedotin and is related.
[2]
One treatment-emergent death occurred in participant with sepsis during treatment with brentuximab vedotin and is not related.
[3]
One treatment-emergent death occurred in participant with lymphoma during treatment with brentuximab vedotin and is not related.
[4]
One treatment-emergent death occurred in participant with pulmonary embolism during treatment with brentuximab vedotin and is 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 Methotrexate or Bexarotene
Affected / at Risk (%) Affected / at Risk (%)
Total   60/66 (90.91%)   51/62 (82.26%) 
Blood and lymphatic system disorders     
Neutropenia  1  5/66 (7.58%)  4/62 (6.45%) 
Anaemia  1  3/66 (4.55%)  6/62 (9.68%) 
Endocrine disorders     
Hypothyroidism  1  0/66 (0.00%)  5/62 (8.06%) 
Eye disorders     
Dry eye  1  0/66 (0.00%)  4/62 (6.45%) 
Gastrointestinal disorders     
Nausea  1  24/66 (36.36%)  9/62 (14.52%) 
Vomiting  1  11/66 (16.67%)  3/62 (4.84%) 
Diarrhoea  1  18/66 (27.27%)  4/62 (6.45%) 
Constipation  1  3/66 (4.55%)  5/62 (8.06%) 
General disorders     
Fatigue  1  18/66 (27.27%)  18/62 (29.03%) 
Asthenia  1  7/66 (10.61%)  5/62 (8.06%) 
Pyrexia  1  9/66 (13.64%)  8/62 (12.90%) 
Oedema peripheral  1  7/66 (10.61%)  6/62 (9.68%) 
Chills  1  4/66 (6.06%)  2/62 (3.23%) 
Peripheral swelling  1  1/66 (1.52%)  4/62 (6.45%) 
Infections and infestations     
Upper respiratory tract infection  1  4/66 (6.06%)  2/62 (3.23%) 
Skin infection  1  2/66 (3.03%)  6/62 (9.68%) 
Urinary tract infection  1  4/66 (6.06%)  4/62 (6.45%) 
Staphylococcal skin infection  1  1/66 (1.52%)  5/62 (8.06%) 
Investigations     
Weight decreased  1  6/66 (9.09%)  2/62 (3.23%) 
Alanine aminotransferase increased  1  3/66 (4.55%)  5/62 (8.06%) 
Aspartate aminotransferase increased  1  1/66 (1.52%)  4/62 (6.45%) 
Blood cholesterol increased  1  0/66 (0.00%)  4/62 (6.45%) 
Blood triglycerides increased  1  0/66 (0.00%)  5/62 (8.06%) 
Metabolism and nutrition disorders     
Decreased appetite  1  10/66 (15.15%)  3/62 (4.84%) 
Hyperglycaemia  1  5/66 (7.58%)  0/62 (0.00%) 
Hyperuricaemia  1  4/66 (6.06%)  2/62 (3.23%) 
Hypertriglyceridaemia  1  1/66 (1.52%)  11/62 (17.74%) 
Hypercholesterolaemia  1  0/66 (0.00%)  4/62 (6.45%) 
Musculoskeletal and connective tissue disorders     
Pain in extremity  1  6/66 (9.09%)  4/62 (6.45%) 
Arthralgia  1  8/66 (12.12%)  4/62 (6.45%) 
Myalgia  1  8/66 (12.12%)  2/62 (3.23%) 
Muscle spasms  1  4/66 (6.06%)  3/62 (4.84%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Cancer pain  1  1/66 (1.52%)  5/62 (8.06%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  31/66 (46.97%)  1/62 (1.61%) 
Peripheral motor neuropathy  1  4/66 (6.06%)  0/62 (0.00%) 
Paraesthesia  1  6/66 (9.09%)  1/62 (1.61%) 
Dysgeusia  1  5/66 (7.58%)  0/62 (0.00%) 
Headache  1  5/66 (7.58%)  6/62 (9.68%) 
Dizziness  1  4/66 (6.06%)  1/62 (1.61%) 
Psychiatric disorders     
Insomnia  1  2/66 (3.03%)  6/62 (9.68%) 
Anxiety  1  0/66 (0.00%)  4/62 (6.45%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  7/66 (10.61%)  0/62 (0.00%) 
Cough  1  2/66 (3.03%)  4/62 (6.45%) 
Skin and subcutaneous tissue disorders     
Alopecia  1  10/66 (15.15%)  2/62 (3.23%) 
Rash maculo-papular  1  7/66 (10.61%)  3/62 (4.84%) 
Urticaria  1  5/66 (7.58%)  1/62 (1.61%) 
Dry skin  1  1/66 (1.52%)  4/62 (6.45%) 
Pruritus  1  11/66 (16.67%)  8/62 (12.90%) 
Pruritus generalised  1  7/66 (10.61%)  1/62 (1.61%) 
Vascular disorders     
Hypertension  1  6/66 (9.09%)  0/62 (0.00%) 
1
Term from vocabulary, MedDRA 21.0
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
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: clinicaltrialregistry@tpna.com
Layout table for additonal information
Responsible Party: Takeda ( Millennium Pharmaceuticals, Inc. )
ClinicalTrials.gov Identifier: NCT01578499     History of Changes
Other Study ID Numbers: C25001
2010-024215-14 ( EudraCT Number )
First Submitted: March 27, 2012
First Posted: April 17, 2012
Results First Submitted: December 9, 2017
Results First Posted: March 16, 2018
Last Update Posted: September 2, 2019