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A Phase 1 Study in Patients With Relapsed or Refractory Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma

Sponsor
Millennium Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01950364
Collaborator
(none)
20
Enrollment
6
Locations
2
Arms
19
Duration (Months)
3.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an open-label trial to estimate the concentrations of brentuximab vedotin in relapsed/refractory Hodgkin lymphoma (HL) or relapsed/refractory systemic anaplastic large cell lymphoma (sALCL) participants treated with either brentuximab vedotin or brentuximab vedotin + rifampicin.

Condition or Disease Intervention/Treatment Phase
  • Drug: brentuximab vedotin
  • Drug: Brentuximab vedotin and rifampicin
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 1 Study to Estimate MMAE Metabolites in Human Plasma and Urine in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma or Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma Receiving Brentuximab Vedotin
Study Start Date :
Nov 1, 2013
Actual Primary Completion Date :
Oct 1, 2014
Actual Study Completion Date :
Jun 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Arm A: Brentuximab vedotin

Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.

Drug: brentuximab vedotin
Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
Other Names:
  • SGN-35

    		•
    Experimental: Arm B: Brentuximab vedotin and rifampicin

    Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.

    Drug: Brentuximab vedotin and rifampicin
    Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
    Other Names:
  • SGN-35

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose [Cycle 1: Predose]

      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).

    2. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose [Cycle 2: Predose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    3. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose [Cycle 3: Predose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    4. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose [Cycle 1: 0.5 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    5. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose [Cycle 2: 0.5 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    6. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose [Cycle 3: 0.5 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    7. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose [Cycle 1: 4 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    8. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose [Cycle 3: 4 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    9. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose [Cycle 1: 24 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    10. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose [Cycle 3: 24 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    11. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose [Cycle 1: 48 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    12. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose [Cycle 3: 48 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    13. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose [Cycle 1: 72 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    14. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose [Cycle 3: 72 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    15. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose [Cycle 1: 96 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    16. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose [Cycle 3: 96 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    17. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose [Cycle 1: 144 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    18. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose [Cycle 3: 144 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    19. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose [Cycle 1: 336 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    20. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose [Cycle 3: 336 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    21. Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose [Cycle 3: 480 hour postdose]

      Metabolites of MMAE includes C4, C5, C7, C8 and C13. The LLQ for all the observations was 0.01 ng/mL.

    22. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose [Cycle 1: Predose]

      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.

    23. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose [Cycle 1: 0-24 hours postdose]

      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.

    24. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose [Cycle 1: 24-48 hours postdose]

      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.

    25. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose [Cycle 1: 48-72 hours postdose]

      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.

    26. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose [Cycle 1: 72-96 hours postdose]

      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.

    27. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose [Cycle 1: 96-120 hours postdose]

      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.

    28. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose [Cycle 1: 120-144 hours postdose]

      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.

    29. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose [Cycle 1: 144-168 hours postdose]

      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.

    30. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose [Cycle 1: 336-360 hours postdose]

      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.

    31. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose [Cycle 1: 480-504 hours postdose]

      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.

    32. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose [Cycle 3: Predose]

      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.

    33. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose [Cycle 3: 0-24 hours postdose]

      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.

    34. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose [Cycle 3: 24-48 hours postdose]

      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.

    35. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose [Cycle 3: 48-72 hours postdose]

      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.

    36. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose [Cycle 3: 72-96 hours postdose]

      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.

    37. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose [Cycle 3: 96-120 hours postdose]

      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.

    38. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose [Cycle 3: 120-144 hours postdose]

      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.

    39. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose [Cycle 3: 144-168 hours postdose]

      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.

    40. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose [Cycle 3: 336-360 hours postdose]

      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.

    41. Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose [Cycle 3: 480-504 hours postdose]

      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.

    Secondary Outcome Measures

    1. Serum Concentrations of Antibody-drug Conjugate (ADC) [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]

      The LLQ for all the observations was 12.5 ng/mL.

    2. Serum Concentration of Total Antibody (TAb) [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]

      The LLQ for all the observations was 12.5 ng/mL.

    3. Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Baseline up to 30 days after last dose of study drug (30 days after Cycle 16)]

      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.

    4. Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin [Day 1 of Cycle 1 and 3]

      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.

    5. Number of Participants With Markedly Abnormal Laboratory Values [Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)]

      The number of participants with any markedly abnormal standard safety laboratory values collected throughout study.

    6. Number of Participants With Clinically Significant Change From Baseline in Vital Signs [Baseline up to 30 days after last dose of study drug (30 Days after Cycle 16)]

      Vital signs included body temperature, body weight, blood pressure and heart rate.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female participants between 18 years and 75 years old, with relapsed or refractory HL or relapsed or refractory sALCL who have previously received at least 1 multiagent chemotherapy

    • Measurable disease

    • An Eastern Cooperative Oncology Group (ECOG) performance of 0 or 1

    • Female participants who are postmenopausal for at least 1 year before the screening visit, surgically sterile, or agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 30 days after the last dose of study drug, or agree to practice true abstinence

    • Male participants who agree to practice effective barrier contraception during the entire study treatment period through 6 months after the last dose of study drug or agree to practice true abstinence

    • Clinical laboratory values as specified in the study protocol

    Exclusion Criteria:

    • Participants for whom rifampicin is contraindicated

    • Previously received an allogeneic transplant.

    • Participants with current diagnosis of primary cutaneous anaplastic large cell lymphoma (ALCL) (participants whose ALCL has transformed to sALCL are eligible).

    • Known cerebral/meningeal disease including signs or symptoms of progressive multifocal leukoencephalopathy (PML)

    • Female participants who are lactating and breastfeeding or pregnant

    • Known human immunodeficiency virus (HIV) positive,

    • Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brussels Belgium
    2 Gent Belgium
    3 Vilnius Lithuania
    4 Barcelona Spain
    5 Madrid Spain
    6 Salamanca Spain

    Sponsors and Collaborators

    • Millennium Pharmaceuticals, Inc.

    Investigators

    • Study Director: Medical Monitor, Millennium Pharmaceuticals, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Millennium Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT01950364
    Other Study ID Numbers:
    • C25005
    • 2013-000193-29
    • U1111-1174-1958
    First Posted:
    Sep 25, 2013
    Last Update Posted:
    May 11, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Millennium Pharmaceuticals, Inc.
    Lymphoma
    Hodgkin
    Anaplastic Large-cell
    Relapsed
    Refractory
    Antigens, CD30
    Antibody-Drug Conjugate
    Antibodies, Monoclonal
    Lymphoma, Non-Hodgkin
    Lymphoma, Large-Cell, Anaplastic
    Monomethyl auristatin E
    Drug Therapy
    Immunotherapy
    Hematologic Diseases
    Additional relevant MeSH terms:
    Lymphoma
    Lymphoma, Non-Hodgkin
    Hodgkin Disease
    Lymphoma, Large-Cell, Anaplastic
    Rifampin
    Brentuximab Vedotin
    Antibodies, Monoclonal

    Study Results

    Participant Flow

    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 Detail 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
    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

    Baseline Characteristics

    Arm/Group Title Brentuximab Vedotin Brentuximab Vedotin + Rifampicin Total
    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 Participants 10 10 20
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    42.3
    (12.15)
    40.1
    (9.13)
    41.2
    (10.52)
    Sex: Female, Male (Count of Participants)
    Female
    3
    30%
    6
    60%
    9
    45%
    Male
    7
    70%
    4
    40%
    11
    55%
    Race/Ethnicity, Customized (participants) [Number]
    White
    10
    100%
    10
    100%
    20
    100%
    Race/Ethnicity, Customized (participants) [Number]
    Not Hispanic or Latino
    10
    100%
    10
    100%
    20
    100%
    Region of Enrollment (participants) [Number]
    Spain
    4
    40%
    5
    50%
    9
    45%
    Belgium
    2
    20%
    1
    10%
    3
    15%
    Lithuania
    4
    40%
    4
    40%
    8
    40%
    Weight (kilogram (kg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kilogram (kg)]
    71.11
    (17.056)
    76.84
    (24.213)
    73.98
    (20.595)
    Height (centimeter (cm)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [centimeter (cm)]
    169.9
    (3.80)
    169.7
    (6.45)
    169.8
    (5.15)
    Eastern Cooperative Oncology Group (ECOG) Performance Status (participants) [Number]
    0
    3
    30%
    6
    60%
    9
    45%
    1
    6
    60%
    4
    40%
    10
    50%
    2
    1
    10%
    0
    0%
    1
    5%
    Disease Type (participants) [Number]
    Hodgkin lymphoma
    10
    100%
    10
    100%
    20
    100%
    sALCL
    0
    0%
    0
    0%
    0
    0%
    Months from Initial Diagnosis to First Dose (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    34.7
    (31.23)
    61.9
    (46.96)
    48.3
    (41.25)
    Ann Arbor Stage (participants) [Number]
    I
    1
    10%
    0
    0%
    1
    5%
    II
    2
    20%
    6
    60%
    8
    40%
    III
    1
    10%
    0
    0%
    1
    5%
    IV
    6
    60%
    4
    40%
    10
    50%

    Outcome Measures

    1. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, Predose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    NA
    (NA)
    NA
    (NA)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    NA
    (NA)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    2. Secondary Outcome
    Title Serum Concentrations of Antibody-drug Conjugate (ADC)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    Cycle 1, Predose
    NA
    (NA)
    NA
    (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)
    3. Secondary Outcome
    Title Serum Concentration of Total Antibody (TAb)
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    Cycle 1, Predose
    NA
    (NA)
    NA
    (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)
    4. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, Predose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.0919
    (0.05695)
    0.0795
    (0.14220)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    NA
    (NA)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    5. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, Predose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.1046
    (0.10840)
    0.0727
    (0.05936)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    NA
    (NA)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    6. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 0.5 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.3902
    (1.33635)
    0.2149
    (0.43900)
    C4
    0.0184
    (0.00613)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0267
    (0.02119)
    NA
    (NA)
    C13
    0.0108
    (0.00360)
    NA
    (NA)
    7. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 2, 0.5 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.3119
    (1.69249)
    0.2929
    (1.39185)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    NA
    (NA)
    0.0228
    (0.00760)
    C13
    NA
    (NA)
    NA
    (NA)
    8. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 0.5 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.3307
    (2.33539)
    0.2577
    (0.26736)
    C4
    0.0256
    (0.00905)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0323
    (0.03266)
    NA
    (NA)
    C13
    0.0210
    (0.00742)
    NA
    (NA)
    9. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 4 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    2.2778
    (4.42089)
    1.7836
    (0.93129)
    C4
    0.0547
    (0.02737)
    NA
    (NA)
    C5
    0.0254
    (0.01326)
    NA
    (NA)
    C7
    0.0195
    (0.01293)
    NA
    (NA)
    C8
    0.0557
    (0.05631)
    0.0160
    (0.00921)
    C13
    0.0151
    (0.00752)
    NA
    (NA)
    10. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 4 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    1.7171
    (4.42914)
    1.4529
    (1.36620)
    C4
    0.0397
    (0.01323)
    NA
    (NA)
    C5
    0.0163
    (0.00804)
    NA
    (NA)
    C7
    0.0118
    (0.00600)
    NA
    (NA)
    C8
    0.0446
    (0.05011)
    0.0190
    (0.01265)
    C13
    0.0191
    (0.00637)
    NA
    (NA)
    11. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 24 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    3.7950
    (4.12446)
    3.1227
    (2.38909)
    C4
    0.0443
    (0.05328)
    0.0191
    (0.00637)
    C5
    0.0218
    (0.02814)
    NA
    (NA)
    C7
    0.0206
    (0.01477)
    NA
    (NA)
    C8
    0.0805
    (0.06986)
    0.0196
    (0.01702)
    C13
    0.0142
    (0.00660)
    0.0113
    (0.00377)
    12. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 24 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    3.2336
    (2.26369)
    2.2558
    (1.60345)
    C4
    0.0200
    (0.01071)
    NA
    (NA)
    C5
    0.0203
    (0.01109)
    NA
    (NA)
    C7
    0.0164
    (0.00868)
    NA
    (NA)
    C8
    0.0715
    (0.04523)
    0.0177
    (0.01284)
    C13
    0.0105
    (0.00371)
    NA
    (NA)
    13. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 48 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    4.2140
    (3.69470)
    3.3727
    (2.61792)
    C4
    0.0424
    (0.05259)
    0.0128
    (0.00565)
    C5
    0.0168
    (0.02553)
    NA
    (NA)
    C7
    0.0187
    (0.01608)
    NA
    (NA)
    C8
    0.0959
    (0.06780)
    0.0210
    (0.01455)
    C13
    0.0134
    (0.00763)
    NA
    (NA)
    14. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 48 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    3.4733
    (2.17792)
    2.2156
    (1.70890)
    C4
    0.0193
    (0.01407)
    NA
    (NA)
    C5
    0.0198
    (0.01316)
    NA
    (NA)
    C7
    0.0170
    (0.01112)
    NA
    (NA)
    C8
    0.0746
    (0.06162)
    0.0195
    (0.01114)
    C13
    0.0124
    (0.00438)
    NA
    (NA)
    15. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 72 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    3.8931
    (3.61834)
    3.0948
    (2.03516)
    C4
    0.0501
    (0.06242)
    0.0127
    (0.00423)
    C5
    0.0190
    (0.02664)
    NA
    (NA)
    C7
    0.0241
    (0.01640)
    NA
    (NA)
    C8
    0.0899
    (0.06688)
    0.0187
    (0.01111)
    C13
    0.0133
    (0.00644)
    NA
    (NA)
    16. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 72 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    3.3047
    (2.14127)
    1.9732
    (1.32391)
    C4
    0.0310
    (0.01563)
    NA
    (NA)
    C5
    0.0256
    (0.01510)
    NA
    (NA)
    C7
    0.0168
    (0.01126)
    NA
    (NA)
    C8
    0.0728
    (0.04348)
    0.0187
    (0.01079)
    C13
    NA
    (NA)
    NA
    (NA)
    17. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 96 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    0.0374
    (0.01247)
    C8
    0.0660
    (0.04349)
    0.0228
    (0.06198)
    C13
    NA
    (NA)
    0.0108
    (0.00360)
    18. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 96 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    19. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 144 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    2.3326
    (1.45619)
    1.7990
    (0.89695)
    C4
    0.0297
    (0.02569)
    NA
    (NA)
    C5
    0.0174
    (0.01006)
    NA
    (NA)
    C7
    0.0196
    (0.00693)
    NA
    (NA)
    C8
    0.0497
    (0.02722)
    0.0120
    (0.00542)
    C13
    NA
    (NA)
    NA
    (NA)
    20. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 144 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    2.0555
    (1.07315)
    1.2920
    (0.75690)
    C4
    0.0198
    (0.00976)
    NA
    (NA)
    C5
    0.0140
    (0.00760)
    NA
    (NA)
    C7
    0.0137
    (0.00484)
    NA
    (NA)
    C8
    0.0441
    (0.02147)
    0.0145
    (0.00648)
    C13
    NA
    (NA)
    NA
    (NA)
    21. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 1, 336 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.3130
    (0.15743)
    0.2723
    (0.16544)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0127
    (0.00672)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    22. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 336 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.4258
    (0.30565)
    0.2578
    (0.10847)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0168
    (0.01011)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    23. Primary Outcome
    Title Plasma Concentration of Monomethylauristatin E (MMAE) and Its Metabolites at Cycle 3, 480 Hour Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.1189
    (0.15808)
    0.0941
    (0.03974)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0114
    (0.00431)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    24. Secondary Outcome
    Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 10 10
    AEs
    9
    90%
    9
    90%
    SAEs
    4
    40%
    0
    0%
    25. Secondary Outcome
    Title Number of Participants With Anti-therapeutic Antibodies (ATA) to Brentuximab Vedotin
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 10 10
    Negative in both Cycle 1 and 3
    5
    50%
    7
    70%
    Positive in both Cycle 1 and 3
    1
    10%
    0
    0%
    Transient Positive
    2
    20%
    2
    20%
    26. Secondary Outcome
    Title Number of Participants With Markedly Abnormal Laboratory Values
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 10 10
    Number [participants]
    5
    50%
    5
    50%
    27. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, Predose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    NA
    (NA)
    7.8900
    (2.63000)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    NA
    (NA)
    0.0712
    (0.02373)
    C13
    NA
    (NA)
    NA
    (NA)
    28. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 0-24 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.5967
    (0.56221)
    0.1047
    (0.07785)
    C13
    0.0786
    (0.11460)
    0.0456
    (0.03714)
    29. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 24-48 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.7275
    (0.59716)
    0.1568
    (0.08381)
    C13
    0.0722
    (0.07482)
    0.0405
    (0.03473)
    30. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 48-72 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.7973
    (0.38226)
    0.1189
    (0.08494)
    C13
    0.0786
    (0.05672)
    0.0382
    (0.02718)
    31. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 72-96 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.7480
    (0.61219)
    0.1247
    (0.08379)
    C13
    0.0754
    (0.06820)
    0.0415
    (0.02723)
    32. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 96-120 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.7360
    (1.02417)
    0.1034
    (0.10563)
    C13
    0.0630
    (0.08155)
    0.0380
    (0.03436)
    33. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 120-144 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.4477
    (0.56047)
    0.0910
    (0.06044)
    C13
    0.0551
    (0.05107)
    0.0345
    (0.01738)
    34. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 144-168 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.3916
    (0.34491)
    0.0706
    (0.03027)
    C13
    0.0438
    (0.03146)
    0.0363
    (0.01283)
    35. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 336-360 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    1.0727
    (0.55233)
    1.3326
    (0.80959)
    C4
    0.0459
    (0.01530)
    NA
    (NA)
    C5
    0.0289
    (0.00963)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0751
    (0.04505)
    0.0401
    (0.02242)
    C13
    NA
    (NA)
    NA
    (NA)
    36. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 1, 480-504 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.4420
    (0.30745)
    0.3505
    (0.14592)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0578
    (0.03314)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    37. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, Predose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.3171
    (0.33548)
    0.4227
    (0.17918)
    C4
    NA
    (NA)
    NA
    (NA)
    C5
    NA
    (NA)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0392
    (0.02985)
    NA
    (NA)
    C13
    NA
    (NA)
    NA
    (NA)
    38. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 0-24 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.4657
    (0.41352)
    0.1285
    (0.17930)
    C13
    0.0516
    (0.07045)
    0.0676
    (0.05022)
    39. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 24-48 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.5750
    (0.58196)
    0.1600
    (0.11946)
    C13
    0.0637
    (0.05102)
    0.0507
    (0.03607)
    40. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 48-72 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.6950
    (0.83588)
    0.1598
    (0.14846)
    C13
    0.0632
    (0.06480)
    0.0746
    (0.05134)
    41. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 72-96 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.5276
    (0.95507)
    0.1510
    (0.11532)
    C13
    0.0573
    (0.07734)
    0.0564
    (0.03759)
    42. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 96-120 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.5198
    (0.79634)
    0.1088
    (0.09569)
    C13
    0.0607
    (0.06838)
    0.0524
    (0.03619)
    43. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 120-144 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.4700
    (0.37131)
    0.0869
    (0.07672)
    C13
    0.0386
    (0.03212)
    0.0429
    (0.02820)
    44. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 144-168 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    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
    (NA)
    NA
    (NA)
    C8
    0.3485
    (0.45898)
    0.0651
    (0.03984)
    C13
    0.0402
    (0.04117)
    0.0481
    (0.01603)
    45. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 336-360 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    1.2811
    (1.55068)
    0.8271
    (0.43597)
    C4
    0.0377
    (0.01812)
    NA
    (NA)
    C5
    0.0347
    (0.02457)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0734
    (0.10958)
    0.0277
    (0.01306)
    C13
    0.0227
    (0.00757)
    NA
    (NA)
    46. Secondary Outcome
    Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs
    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)

    Outcome Measure Data

    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
    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.
    Measure Participants 10 10
    Number [participants]
    1
    10%
    2
    20%
    47. Primary Outcome
    Title Amount of Monomethylauristatin E (MMAE) and Its Metabolites Excreted in Urine at Cycle 3, 480-504 Hours Postdose
    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

    Outcome Measure Data

    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
    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.
    Measure Participants 9 9
    MMAE
    0.4660
    (0.41713)
    0.3334
    (0.25074)
    C4
    0.0248
    (0.00827)
    NA
    (NA)
    C5
    0.0377
    (0.01257)
    NA
    (NA)
    C7
    NA
    (NA)
    NA
    (NA)
    C8
    0.0620
    (0.04967)
    0.0221
    (0.00737)
    C13
    NA
    (NA)
    NA
    (NA)

    Adverse Events

    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
    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 (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN)
    Serious Adverse Events
    Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/10 (40%) 0/10 (0%)
    General disorders
    Thrombosis in device 1/10 (10%) 0/10 (0%)
    Pyrexia 1/10 (10%) 0/10 (0%)
    Infections and infestations
    Staphylococcal infection 1/10 (10%) 0/10 (0%)
    Pulmonary tuberculosis 1/10 (10%) 0/10 (0%)
    Pneumocystis jirovecii pneumonia 1/10 (10%) 0/10 (0%)
    Nervous system disorders
    Neuralgia 1/10 (10%) 0/10 (0%)
    Respiratory, thoracic and mediastinal disorders
    Respiratory failure 2/10 (20%) 0/10 (0%)
    Pulmonary embolism 1/10 (10%) 0/10 (0%)
    Other (Not Including Serious) Adverse Events
    Brentuximab Vedotin Brentuximab Vedotin + Rifampicin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/10 (90%) 9/10 (90%)
    Blood and lymphatic system disorders
    Neutropenia 3/10 (30%) 2/10 (20%)
    Anaemia 2/10 (20%) 2/10 (20%)
    Eosinophilia 1/10 (10%) 2/10 (20%)
    Thrombocytopenia 2/10 (20%) 0/10 (0%)
    Leukopenia 0/10 (0%) 1/10 (10%)
    Cardiac disorders
    Sinus tachycardia 1/10 (10%) 2/10 (20%)
    Eye disorders
    Dry eye 1/10 (10%) 0/10 (0%)
    Glaucoma 1/10 (10%) 0/10 (0%)
    Gastrointestinal disorders
    Diarrhoea 1/10 (10%) 2/10 (20%)
    Nausea 1/10 (10%) 1/10 (10%)
    Vomiting 2/10 (20%) 0/10 (0%)
    Abdominal distension 0/10 (0%) 1/10 (10%)
    Abdominal pain upper 1/10 (10%) 0/10 (0%)
    Anal haemorrhage 1/10 (10%) 0/10 (0%)
    General disorders
    Pyrexia 1/10 (10%) 2/10 (20%)
    Fatigue 1/10 (10%) 1/10 (10%)
    Asthenia 0/10 (0%) 1/10 (10%)
    Chills 1/10 (10%) 0/10 (0%)
    Injection site pain 0/10 (0%) 1/10 (10%)
    Local swelling 1/10 (10%) 0/10 (0%)
    Localised oedema 1/10 (10%) 0/10 (0%)
    Oedema peripheral 0/10 (0%) 1/10 (10%)
    Infections and infestations
    Herpes zoster 0/10 (0%) 2/10 (20%)
    Cystitis 1/10 (10%) 0/10 (0%)
    Lung infection 1/10 (10%) 0/10 (0%)
    Oral herpes 0/10 (0%) 1/10 (10%)
    Viral infection 1/10 (10%) 0/10 (0%)
    Injury, poisoning and procedural complications
    Scratch 1/10 (10%) 0/10 (0%)
    Wound 0/10 (0%) 1/10 (10%)
    Investigations
    Blood urea increased 1/10 (10%) 0/10 (0%)
    Body temperature increased 1/10 (10%) 0/10 (0%)
    Weight increased 0/10 (0%) 1/10 (10%)
    Metabolism and nutrition disorders
    Hypokalaemia 2/10 (20%) 1/10 (10%)
    Hypomagnesaemia 2/10 (20%) 1/10 (10%)
    Hyponatraemia 1/10 (10%) 1/10 (10%)
    Decreased appetite 1/10 (10%) 0/10 (0%)
    Diabetes mellitus 1/10 (10%) 0/10 (0%)
    Hyperglycaemia 1/10 (10%) 0/10 (0%)
    Hypocalcaemia 1/10 (10%) 0/10 (0%)
    Hypochloraemia 0/10 (0%) 1/10 (10%)
    Musculoskeletal and connective tissue disorders
    Arthralgia 0/10 (0%) 1/10 (10%)
    Back pain 1/10 (10%) 0/10 (0%)
    Bone pain 1/10 (10%) 0/10 (0%)
    Joint stiffness 0/10 (0%) 1/10 (10%)
    Musculoskeletal chest pain 0/10 (0%) 1/10 (10%)
    Muscle spasms 1/10 (10%) 0/10 (0%)
    Nervous system disorders
    Peripheral sensory neuropathy 1/10 (10%) 2/10 (20%)
    Peripheral motor neuropathy 1/10 (10%) 1/10 (10%)
    Dizziness 0/10 (0%) 1/10 (10%)
    Psychiatric disorders
    Anxiety 0/10 (0%) 1/10 (10%)
    Depression 1/10 (10%) 0/10 (0%)
    Insomnia 1/10 (10%) 0/10 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea 1/10 (10%) 2/10 (20%)
    Cough 1/10 (10%) 0/10 (0%)
    Oropharyngeal pain 1/10 (10%) 0/10 (0%)
    Productive cough 1/10 (10%) 0/10 (0%)
    Sneezing 1/10 (10%) 0/10 (0%)
    Skin and subcutaneous tissue disorders
    Pruritus 3/10 (30%) 3/10 (30%)
    Toxic skin eruption 0/10 (0%) 2/10 (20%)
    Erythema 1/10 (10%) 0/10 (0%)
    Psoriasis 0/10 (0%) 1/10 (10%)
    Rash maculo-papular 0/10 (0%) 1/10 (10%)
    Skin lesion 0/10 (0%) 1/10 (10%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    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

    Name/Title Medical Director
    Organization Takeda
    Phone +1-877-825-3327
    Email trialdisclosures@takeda.com
    Responsible Party:
    Millennium Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT01950364
    Other Study ID Numbers:
    • C25005
    • 2013-000193-29
    • U1111-1174-1958
    First Posted:
    Sep 25, 2013
    Last Update Posted:
    May 11, 2016
    Last Verified:
    Mar 1, 2016