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Trial record 12 of 882 for:    "Reticulum Cell Sarcoma"

A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell 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: NCT01950364
Recruitment Status : Completed
First Posted : September 25, 2013
Results First Posted : February 9, 2016
Last Update Posted : May 11, 2016
Sponsor:
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hodgkin Lymphoma
Anaplastic Large-cell Lymphoma
Interventions Drug: brentuximab vedotin
Drug: Brentuximab vedotin and rifampicin
Enrollment 20
Recruitment Details Participants took part in the study at 5 investigative sites in Belgium, Lithuania and Spain from 27 November 2013 to 16 June 2015.
Pre-assignment Details Participants with a historical diagnosis of relapsed or refractory classical hodgkin lymphoma (HL) or relapsed or refractory systemic anaplastic large cell lymphoma (sALCL) were enrolled in 1 of 2 treatment groups: Brentuximab vedotin; Brentuximab vedotin + Rifampicin.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses. Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Period Title: Overall Study
Started 10 10
Completed 0 0
Not Completed 10 10
Reason Not Completed
Adverse Event             3             0
Stem Cell Transplant             2             6
Disease Progression             5             2
Withdrawal by Subject             0             1
Protocol Violation             0             1
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin Total
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses. Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
Safety population included all participants who received at least 1 dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
42.3  (12.15) 40.1  (9.13) 41.2  (10.52)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
3
  30.0%
6
  60.0%
9
  45.0%
Male
7
  70.0%
4
  40.0%
11
  55.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
White Number Analyzed 10 participants 10 participants 20 participants
10 10 20
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Not Hispanic or Latino Number Analyzed 10 participants 10 participants 20 participants
10 10 20
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Spain 4 5 9
Belgium 2 1 3
Lithuania 4 4 8
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram (kg)
Number Analyzed 10 participants 10 participants 20 participants
71.11  (17.056) 76.84  (24.213) 73.98  (20.595)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeter (cm)
Number Analyzed 10 participants 10 participants 20 participants
169.9  (3.80) 169.7  (6.45) 169.8  (5.15)
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
0 3 6 9
1 6 4 10
2 1 0 1
[1]
Measure Description: ECOG performance status is used to assess how the disease affects the daily living abilities of the participant. It ranges on the scale from 0-5 (0= normal activity; 1= symptoms but ambulatory; 2= in bed for less than (<) 50 percent (%) of the time; 3= in bed for greater than (>) 50% of the time; 4= 100% bedridden; 5= dead.
Disease Type  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Hodgkin lymphoma 10 10 20
sALCL 0 0 0
Months from Initial Diagnosis to First Dose  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 10 participants 10 participants 20 participants
34.7  (31.23) 61.9  (46.96) 48.3  (41.25)
Ann Arbor Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
I 1 0 1
II 2 6 8
III 1 0 1
IV 6 4 10
[1]
Measure Description: Ann Arbor staging is staging system for lymphomas. The stage is determined by location of tumor. Stage I (located in a single region, usually 1 lymph node and surrounding area), Stage II (located in 2 separate regions, an affected lymph node or organ and a second affected area, and both affected areas are confined to 1 side of diaphragm), Stage III (spread to both sides of diaphragm, including organ/area near lymph nodes/spleen), Stage IV (diffuse or disseminated involvement of 1 or more extra lymphatic organs, including any involvement of liver, bone marrow or nodular involvement of lungs).
1.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The lower limit of Quantification (LLQ) for all the observations was 0.01 nanogram/milliliter (ng/mL).
Time Frame Cycle 1: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic (PK) analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE NA [1]   (NA) NA [1]   (NA)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 NA [1]   (NA) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
2.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 2: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.0919  (0.05695) 0.0795  (0.14220)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 NA [1]   (NA) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
3.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.1046  (0.10840) 0.0727  (0.05936)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 NA [1]   (NA) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
4.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 0.5 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.3902  (1.33635) 0.2149  (0.43900)
C4 0.0184  (0.00613) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0267  (0.02119) NA [1]   (NA)
C13 0.0108  (0.00360) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
5.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 2: 0.5 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.3119  (1.69249) 0.2929  (1.39185)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 NA [1]   (NA) 0.0228  (0.00760)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
6.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 0.5 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.3307  (2.33539) 0.2577  (0.26736)
C4 0.0256  (0.00905) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0323  (0.03266) NA [1]   (NA)
C13 0.0210  (0.00742) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
7.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 4 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 2.2778  (4.42089) 1.7836  (0.93129)
C4 0.0547  (0.02737) NA [1]   (NA)
C5 0.0254  (0.01326) NA [1]   (NA)
C7 0.0195  (0.01293) NA [1]   (NA)
C8 0.0557  (0.05631) 0.0160  (0.00921)
C13 0.0151  (0.00752) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
8.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 4 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 1.7171  (4.42914) 1.4529  (1.36620)
C4 0.0397  (0.01323) NA [1]   (NA)
C5 0.0163  (0.00804) NA [1]   (NA)
C7 0.0118  (0.00600) NA [1]   (NA)
C8 0.0446  (0.05011) 0.0190  (0.01265)
C13 0.0191  (0.00637) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
9.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 24 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 3.7950  (4.12446) 3.1227  (2.38909)
C4 0.0443  (0.05328) 0.0191  (0.00637)
C5 0.0218  (0.02814) NA [1]   (NA)
C7 0.0206  (0.01477) NA [1]   (NA)
C8 0.0805  (0.06986) 0.0196  (0.01702)
C13 0.0142  (0.00660) 0.0113  (0.00377)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
10.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 24 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 3.2336  (2.26369) 2.2558  (1.60345)
C4 0.0200  (0.01071) NA [1]   (NA)
C5 0.0203  (0.01109) NA [1]   (NA)
C7 0.0164  (0.00868) NA [1]   (NA)
C8 0.0715  (0.04523) 0.0177  (0.01284)
C13 0.0105  (0.00371) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
11.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 48 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 4.2140  (3.69470) 3.3727  (2.61792)
C4 0.0424  (0.05259) 0.0128  (0.00565)
C5 0.0168  (0.02553) NA [1]   (NA)
C7 0.0187  (0.01608) NA [1]   (NA)
C8 0.0959  (0.06780) 0.0210  (0.01455)
C13 0.0134  (0.00763) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
12.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 48 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 3.4733  (2.17792) 2.2156  (1.70890)
C4 0.0193  (0.01407) NA [1]   (NA)
C5 0.0198  (0.01316) NA [1]   (NA)
C7 0.0170  (0.01112) NA [1]   (NA)
C8 0.0746  (0.06162) 0.0195  (0.01114)
C13 0.0124  (0.00438) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
13.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 72 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 3.8931  (3.61834) 3.0948  (2.03516)
C4 0.0501  (0.06242) 0.0127  (0.00423)
C5 0.0190  (0.02664) NA [1]   (NA)
C7 0.0241  (0.01640) NA [1]   (NA)
C8 0.0899  (0.06688) 0.0187  (0.01111)
C13 0.0133  (0.00644) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
14.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 72 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 3.3047  (2.14127) 1.9732  (1.32391)
C4 0.0310  (0.01563) NA [1]   (NA)
C5 0.0256  (0.01510) NA [1]   (NA)
C7 0.0168  (0.01126) NA [1]   (NA)
C8 0.0728  (0.04348) 0.0187  (0.01079)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
15.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 96 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 2.9148  (1.70500) 3.2956  (2.97022)
C4 0.0136  (0.00481) 0.1420  (0.04733)
C5 0.0120  (0.00643) 0.0593  (0.01977)
C7 NA [1]   (NA) 0.0374  (0.01247)
C8 0.0660  (0.04349) 0.0228  (0.06198)
C13 NA [1]   (NA) 0.0108  (0.00360)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
16.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 96 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 2.4449  (1.44334) 2.2344  (1.81211)
C4 0.0140  (0.00704) 0.0418  (0.01393)
C5 0.0205  (0.01017) 0.0294  (0.00980)
C7 0.0121  (0.00428) 0.0252  (0.00840)
C8 0.0622  (0.04328) 0.0392  (0.04163)
C13 0.0105  (0.00371) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
17.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 144 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 2.3326  (1.45619) 1.7990  (0.89695)
C4 0.0297  (0.02569) NA [1]   (NA)
C5 0.0174  (0.01006) NA [1]   (NA)
C7 0.0196  (0.00693) NA [1]   (NA)
C8 0.0497  (0.02722) 0.0120  (0.00542)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
18.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 144 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 2.0555  (1.07315) 1.2920  (0.75690)
C4 0.0198  (0.00976) NA [1]   (NA)
C5 0.0140  (0.00760) NA [1]   (NA)
C7 0.0137  (0.00484) NA [1]   (NA)
C8 0.0441  (0.02147) 0.0145  (0.00648)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
19.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 1: 336 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.3130  (0.15743) 0.2723  (0.16544)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0127  (0.00672) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
20.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 336 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.4258  (0.30565) 0.2578  (0.10847)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0168  (0.01011) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
21.Primary Outcome
Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.
Time Frame Cycle 3: 480 hour postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
MMAE 0.1189  (0.15808) 0.0941  (0.03974)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0114  (0.00431) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
22.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE NA [1]   (NA) 7.8900  (2.63000)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 NA [1]   (NA) 0.0712  (0.02373)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
23.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 0-24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 12.5668  (5.31374) 12.5020  (6.85958)
C4 0.0878  (0.13223) 0.0521  (0.02335)
C5 0.0883  (0.10135) 0.0254  (0.00847)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.5967  (0.56221) 0.1047  (0.07785)
C13 0.0786  (0.11460) 0.0456  (0.03714)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
24.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 24-48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 12.6225  (6.93735) 11.7995  (6.20286)
C4 0.0690  (0.10935) 0.0392  (0.03010)
C5 0.0863  (0.09138) 0.0277  (0.01700)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.7275  (0.59716) 0.1568  (0.08381)
C13 0.0722  (0.07482) 0.0405  (0.03473)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
25.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 48-72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 12.4089  (4.49922) 11.6600  (5.45329)
C4 0.0812  (0.15006) 0.0419  (0.02694)
C5 0.0867  (0.10841) 0.0322  (0.01859)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.7973  (0.38226) 0.1189  (0.08494)
C13 0.0786  (0.05672) 0.0382  (0.02718)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
26.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 72-96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 10.7766  (8.14858) 12.8426  (5.93538)
C4 0.0867  (0.16449) 0.0427  (0.02848)
C5 0.0882  (0.11202) 0.0394  (0.02131)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.7480  (0.61219) 0.1247  (0.08379)
C13 0.0754  (0.06820) 0.0415  (0.02723)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
27.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 96-120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 10.8018  (12.03431) 9.5626  (7.26020)
C4 0.0885  (0.11811) 0.0414  (0.03529)
C5 0.1053  (0.10639) 0.0406  (0.02753)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.7360  (1.02417) 0.1034  (0.10563)
C13 0.0630  (0.08155) 0.0380  (0.03436)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
28.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 120-144 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 6.7161  (6.13997) 7.9830  (4.33309)
C4 0.0730  (0.08387) 0.0335  (0.02037)
C5 0.0836  (0.07377) 0.0301  (0.01767)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.4477  (0.56047) 0.0910  (0.06044)
C13 0.0551  (0.05107) 0.0345  (0.01738)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
29.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 144-168 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 5.5693  (3.50945) 5.8025  (3.45889)
C4 0.0579  (0.06807) 0.0448  (0.02158)
C5 0.0747  (0.05078) 0.0287  (0.01527)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.3916  (0.34491) 0.0706  (0.03027)
C13 0.0438  (0.03146) 0.0363  (0.01283)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
30.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 336-360 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 1.0727  (0.55233) 1.3326  (0.80959)
C4 0.0459  (0.01530) NA [1]   (NA)
C5 0.0289  (0.00963) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0751  (0.04505) 0.0401  (0.02242)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
31.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 1: 480-504 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 0.4420  (0.30745) 0.3505  (0.14592)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0578  (0.03314) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
32.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: Predose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 0.3171  (0.33548) 0.4227  (0.17918)
C4 NA [1]   (NA) NA [1]   (NA)
C5 NA [1]   (NA) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0392  (0.02985) NA [1]   (NA)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
33.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 0-24 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 10.7174  (15.35912) 12.4438  (8.86144)
C4 0.0454  (0.07644) 0.0451  (0.02977)
C5 0.0509  (0.04623) 0.0301  (0.01847)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.4657  (0.41352) 0.1285  (0.17930)
C13 0.0516  (0.07045) 0.0676  (0.05022)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
34.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 24-48 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 11.1360  (6.73693) 13.2483  (4.79482)
C4 0.0604  (0.05049) 0.0413  (0.03095)
C5 0.0808  (0.06838) 0.0311  (0.02021)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.5750  (0.58196) 0.1600  (0.11946)
C13 0.0637  (0.05102) 0.0507  (0.03607)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
35.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 48-72 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 12.7267  (8.96991) 13.8072  (8.63973)
C4 0.0620  (0.06222) 0.0524  (0.04691)
C5 0.0746  (0.09237) 0.0406  (0.03034)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.6950  (0.83588) 0.1598  (0.14846)
C13 0.0632  (0.06480) 0.0746  (0.05134)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
36.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 72-96 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 11.2527  (8.65574) 12.2263  (6.09003)
C4 0.0702  (0.07079) 0.0611  (0.05055)
C5 0.0937  (0.10757) 0.0437  (0.03084)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.5276  (0.95507) 0.1510  (0.11532)
C13 0.0573  (0.07734) 0.0564  (0.03759)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
37.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 96-120 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 8.3817  (7.78279) 8.1426  (7.29530)
C4 0.0710  (0.05912) 0.0512  (0.04137)
C5 0.0916  (0.08893) 0.0435  (0.02885)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.5198  (0.79634) 0.1088  (0.09569)
C13 0.0607  (0.06838) 0.0524  (0.03619)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
38.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 120-144 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 7.3500  (3.78427) 7.5871  (4.66863)
C4 0.0461  (0.03666) 0.0520  (0.03870)
C5 0.0657  (0.04811) 0.0342  (0.02508)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.4700  (0.37131) 0.0869  (0.07672)
C13 0.0386  (0.03212) 0.0429  (0.02820)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
39.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 144-168 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 6.1125  (3.83207) 4.6823  (2.80767)
C4 0.0538  (0.04252) 0.0562  (0.02674)
C5 0.0662  (0.06110) 0.0308  (0.01718)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.3485  (0.45898) 0.0651  (0.03984)
C13 0.0402  (0.04117) 0.0481  (0.01603)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
40.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 336-360 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 1.2811  (1.55068) 0.8271  (0.43597)
C4 0.0377  (0.01812) NA [1]   (NA)
C5 0.0347  (0.02457) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0734  (0.10958) 0.0277  (0.01306)
C13 0.0227  (0.00757) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
41.Primary Outcome
Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
Hide Description Metabolites of MMAE includes C4, C5, C7, C8 and C13. Amount of MMAE and its metabolites in urine were determined by multiplying the volume of urine obtained and the concentration of MMAE and its metabolites present in it, respectively. The LLQ for determining the concentration was 0.01 ng/mL.
Time Frame Cycle 3: 480-504 hours postdose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng
MMAE 0.4660  (0.41713) 0.3334  (0.25074)
C4 0.0248  (0.00827) NA [1]   (NA)
C5 0.0377  (0.01257) NA [1]   (NA)
C7 NA [1]   (NA) NA [1]   (NA)
C8 0.0620  (0.04967) 0.0221  (0.00737)
C13 NA [1]   (NA) NA [1]   (NA)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
42.Secondary Outcome
Title Serum Concentrations of Antibody-drug Conjugate (ADC)
Hide Description The LLQ for all the observations was 12.5 ng/mL.
Time Frame Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Predose NA [1]   (NA) NA [1]   (NA)
Cycle 1, 0.5 hour 29609.7759  (11865.35702) 33125.0025  (10398.79403)
Cycle 1, 4 hour 24398.6482  (8092.41448) 24533.2372  (6767.70744)
Cycle 1, 72 hour 4265.7542  (2880.39660) 5958.0569  (1788.56378)
Cycle 1, 336 hour 1167.0713  (740.05650) 1108.6515  (376.81123)
Cycle 2, Predose 794.3851  (10732.46886) 435.1550  (303.25245)
Cycle 2, 0.5 hour 16032.6494  (15714.59821) 31627.2566  (6716.71906)
Cycle 3, Predose 611.0573  (786.52082) 536.3692  (524.72923)
Cycle 3, 0.5 hour 20991.9618  (12662.05087) 33040.2245  (6295.45517)
Cycle 3, 4 hour 15378.8274  (9550.99903) 24496.7203  (4212.84997)
Cycle 3, 72 hour 3258.7237  (3358.78504) 4262.0364  (2431.24647)
Cycle 3, 336 hour 1381.2290  (1224.66857) 1363.9488  (789.04877)
Cycle 3, 480 hour 648.2492  (1065.26404) 734.5557  (634.23889)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
43.Secondary Outcome
Title Serum Concentration of Total Antibody (TAb)
Hide Description The LLQ for all the observations was 12.5 ng/mL.
Time Frame Cycle 1 and 3: Predose, 0.5, 4, 72, 336 hours post-dose; Cycle 2: Predose, 0.5 hours post-dose; Cycle 3: 480 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PK analysis set included all participants who received brentuximab vedotin at 1.8 mg/kg throughout Cycles 1 to 3 and had sufficient dosing and PK data to reliably estimate PK parameters.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 9 9
Geometric Mean (Standard Deviation)
Unit of Measure: ng/mL
Cycle 1, Predose NA [1]   (NA) NA [1]   (NA)
Cycle 1, 0.5 hour 30874.4957  (11904.18494) 30884.9074  (9956.67036)
Cycle 1, 4 hour 28577.3869  (9365.88746) 28865.4674  (8192.50406)
Cycle 1, 72 hour 9931.2943  (4973.74692) 11626.2147  (4396.55604)
Cycle 1, 336 hour 2898.2924  (1831.73997) 3066.5859  (1017.84204)
Cycle 2, Predose 2055.3871  (10312.91280) 1363.8319  (904.27346)
Cycle 2, 0.5 hour 17378.2105  (17543.51968) 31583.7793  (7742.69918)
Cycle 3, Predose 1361.3147  (1592.89993) 1517.6506  (1200.68646)
Cycle 3, 0.5 hour 15974.3723  (12467.10368) 33892.4731  (10595.70675)
Cycle 3, 4 hour 11609.1430  (14719.69968) 27548.1773  (7219.71925)
Cycle 3, 72 hour 13594.2016  (7492.70742) 9588.9374  (5665.38218)
Cycle 3, 336 hour 3206.6925  (3000.22116) 3628.9175  (1802.66091)
Cycle 3, 480 hour 1329.0886  (2024.17213) 1866.5746  (1326.12113)
[1]
None of the participants had data above LLQ and as per the predefined protocol results were to be summarized only for observations above LLQ, hence, data was not reported.
44.Secondary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
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. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. AEs included both SAE and non-SAE.
Time Frame Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
AEs 9 9
SAEs 4 0
45.Secondary Outcome
Title Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
Hide Description Participants with positive ATA at both Cycle 1 and 3, negative ATA at both Cycle 1 and 3, and transient positive (positive at one time point, but negative at the other) ATA for brentuximab vedotin were reported.
Time Frame Day 1 of Cycle 1 and 3
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
Negative in both Cycle 1 and 3 5 7
Positive in both Cycle 1 and 3 1 0
Transient Positive 2 2
46.Secondary Outcome
Title Number of Participants With Markedly Abnormal Laboratory Values
Hide Description The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.
Time Frame Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
5 5
47.Secondary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Hide Description Vital signs included body temperature, body weight, blood pressure and heart rate.
Time Frame Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who received at least 1 dose of study drug.
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description:
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
Overall Number of Participants Analyzed 10 10
Measure Type: Number
Unit of Measure: participants
1 2
Time Frame Treatment-emergent adverse events are adverse events that started after the first dose of study drug and no more than 30 days after the last dose of study drug (30 days after Cycle 16).
Adverse Event Reporting Description Serious and non-serious AEs were collected from first dose through 30 days after the last dose (Cycle 16). Beginning on Cycle 4 Day 1, only AEs with Grade 3 were recorded. Exceptions: New onset AEs of Grade 1-2 were recorded if they met criteria for SAEs or resulted in dose modification; PN events will be recorded regardless of severity grade.
 
Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Hide Arm/Group Description Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses. Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
All-Cause Mortality
Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Affected / at Risk (%) Affected / at Risk (%)
Total   4/10 (40.00%)   0/10 (0.00%) 
General disorders     
Thrombosis in device  1  1/10 (10.00%)  0/10 (0.00%) 
Pyrexia  1  1/10 (10.00%)  0/10 (0.00%) 
Infections and infestations     
Staphylococcal infection  1  1/10 (10.00%)  0/10 (0.00%) 
Pulmonary tuberculosis  1  1/10 (10.00%)  0/10 (0.00%) 
Pneumocystis jirovecii pneumonia  1  1/10 (10.00%)  0/10 (0.00%) 
Nervous system disorders     
Neuralgia  1  1/10 (10.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory failure  1  2/10 (20.00%)  0/10 (0.00%) 
Pulmonary embolism  1  1/10 (10.00%)  0/10 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
Affected / at Risk (%) Affected / at Risk (%)
Total   9/10 (90.00%)   9/10 (90.00%) 
Blood and lymphatic system disorders     
Neutropenia  1  3/10 (30.00%)  2/10 (20.00%) 
Anaemia  1  2/10 (20.00%)  2/10 (20.00%) 
Eosinophilia  1  1/10 (10.00%)  2/10 (20.00%) 
Thrombocytopenia  1  2/10 (20.00%)  0/10 (0.00%) 
Leukopenia  1  0/10 (0.00%)  1/10 (10.00%) 
Cardiac disorders     
Sinus tachycardia  1  1/10 (10.00%)  2/10 (20.00%) 
Eye disorders     
Dry eye  1  1/10 (10.00%)  0/10 (0.00%) 
Glaucoma  1  1/10 (10.00%)  0/10 (0.00%) 
Gastrointestinal disorders     
Diarrhoea  1  1/10 (10.00%)  2/10 (20.00%) 
Nausea  1  1/10 (10.00%)  1/10 (10.00%) 
Vomiting  1  2/10 (20.00%)  0/10 (0.00%) 
Abdominal distension  1  0/10 (0.00%)  1/10 (10.00%) 
Abdominal pain upper  1  1/10 (10.00%)  0/10 (0.00%) 
Anal haemorrhage  1  1/10 (10.00%)  0/10 (0.00%) 
General disorders     
Pyrexia  1  1/10 (10.00%)  2/10 (20.00%) 
Fatigue  1  1/10 (10.00%)  1/10 (10.00%) 
Asthenia  1  0/10 (0.00%)  1/10 (10.00%) 
Chills  1  1/10 (10.00%)  0/10 (0.00%) 
Injection site pain  1  0/10 (0.00%)  1/10 (10.00%) 
Local swelling  1  1/10 (10.00%)  0/10 (0.00%) 
Localised oedema  1  1/10 (10.00%)  0/10 (0.00%) 
Oedema peripheral  1  0/10 (0.00%)  1/10 (10.00%) 
Infections and infestations     
Herpes zoster  1  0/10 (0.00%)  2/10 (20.00%) 
Cystitis  1  1/10 (10.00%)  0/10 (0.00%) 
Lung infection  1  1/10 (10.00%)  0/10 (0.00%) 
Oral herpes  1  0/10 (0.00%)  1/10 (10.00%) 
Viral infection  1  1/10 (10.00%)  0/10 (0.00%) 
Injury, poisoning and procedural complications     
Scratch  1  1/10 (10.00%)  0/10 (0.00%) 
Wound  1  0/10 (0.00%)  1/10 (10.00%) 
Investigations     
Blood urea increased  1  1/10 (10.00%)  0/10 (0.00%) 
Body temperature increased  1  1/10 (10.00%)  0/10 (0.00%) 
Weight increased  1  0/10 (0.00%)  1/10 (10.00%) 
Metabolism and nutrition disorders     
Hypokalaemia  1  2/10 (20.00%)  1/10 (10.00%) 
Hypomagnesaemia  1  2/10 (20.00%)  1/10 (10.00%) 
Hyponatraemia  1  1/10 (10.00%)  1/10 (10.00%) 
Decreased appetite  1  1/10 (10.00%)  0/10 (0.00%) 
Diabetes mellitus  1  1/10 (10.00%)  0/10 (0.00%) 
Hyperglycaemia  1  1/10 (10.00%)  0/10 (0.00%) 
Hypocalcaemia  1  1/10 (10.00%)  0/10 (0.00%) 
Hypochloraemia  1  0/10 (0.00%)  1/10 (10.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  0/10 (0.00%)  1/10 (10.00%) 
Back pain  1  1/10 (10.00%)  0/10 (0.00%) 
Bone pain  1  1/10 (10.00%)  0/10 (0.00%) 
Joint stiffness  1  0/10 (0.00%)  1/10 (10.00%) 
Musculoskeletal chest pain  1  0/10 (0.00%)  1/10 (10.00%) 
Muscle spasms  1  1/10 (10.00%)  0/10 (0.00%) 
Nervous system disorders     
Peripheral sensory neuropathy  1  1/10 (10.00%)  2/10 (20.00%) 
Peripheral motor neuropathy  1  1/10 (10.00%)  1/10 (10.00%) 
Dizziness  1  0/10 (0.00%)  1/10 (10.00%) 
Psychiatric disorders     
Anxiety  1  0/10 (0.00%)  1/10 (10.00%) 
Depression  1  1/10 (10.00%)  0/10 (0.00%) 
Insomnia  1  1/10 (10.00%)  0/10 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea  1  1/10 (10.00%)  2/10 (20.00%) 
Cough  1  1/10 (10.00%)  0/10 (0.00%) 
Oropharyngeal pain  1  1/10 (10.00%)  0/10 (0.00%) 
Productive cough  1  1/10 (10.00%)  0/10 (0.00%) 
Sneezing  1  1/10 (10.00%)  0/10 (0.00%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  3/10 (30.00%)  3/10 (30.00%) 
Toxic skin eruption  1  0/10 (0.00%)  2/10 (20.00%) 
Erythema  1  1/10 (10.00%)  0/10 (0.00%) 
Psoriasis  1  0/10 (0.00%)  1/10 (10.00%) 
Rash maculo-papular  1  0/10 (0.00%)  1/10 (10.00%) 
Skin lesion  1  0/10 (0.00%)  1/10 (10.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
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: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01950364     History of Changes
Other Study ID Numbers: C25005
2013-000193-29 ( EudraCT Number )
U1111-1174-1958 ( Registry Identifier: WHO )
First Submitted: September 23, 2013
First Posted: September 25, 2013
Results First Submitted: October 30, 2015
Results First Posted: February 9, 2016
Last Update Posted: May 11, 2016