Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

December 17, 2014 updated by: Seagen Inc.

An Open-Label Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35) in Patients With CD30-Positive Hematologic Malignancies: CYP3A4 Drug-Drug Interactions, Excretion, and Special Populations

The purpose of this study is to identify brentuximab vedotin drug-drug interactions in patients with CD30-positive cancers and to determine the main route of excretion. The study will also assess blood drug levels in patients with renal or hepatic impairment (special populations).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

73

Phase

  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • City of Hope
    • Colorado
      • Denver, Colorado, United States, 80218
        • Colorado Blood Cancer Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Medical Group Oncology & Hematology Specialists
    • Michigan
      • Detroit, Michigan, United States, 48209
        • Karmanos Cancer Institute / Wayne State University
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
    • Washington
      • Seattle, Washington, United States, 98109-1023
        • Seattle Cancer Care Alliance / University of Washington Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adequate organ function (Special Populations: serum bilirubin >2 mg/dL or creatinine clearance <50 mL/min)
  • ECOG performance status <2 (Special Populations: <4)
  • Relapsed or refractory CD30-positive malignancy

Exclusion Criteria:

  • Receiving prohibited medication within 4 weeks
  • Poor liver function (Child-Pugh class C)
  • Current diagnosis of primary cutaneous ALCL
  • Acute or chronic graft-versus-host disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
midazolam +/- brentuximab vedotin
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Names:
  • ADCETRIS; SGN-35
Drug: midazolam
1 mg IV
Drug: brentuximab vedotin
1.2 mg/kg IV every 21 days
Other Names:
  • SGN-35
Experimental: 2
brentuximab vedotin +/- rifampin
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Names:
  • ADCETRIS; SGN-35
Drug: brentuximab vedotin
1.2 mg/kg IV every 21 days
Other Names:
  • SGN-35
Drug: rifampin
600 mg/day PO
Experimental: 3
brentuximab vedotin +/- ketoconazole
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Names:
  • ADCETRIS; SGN-35
Drug: brentuximab vedotin
1.2 mg/kg IV every 21 days
Other Names:
  • SGN-35
Drug: ketoconazole
400 mg/day PO
Experimental: 4
special populations
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Names:
  • ADCETRIS; SGN-35
Drug: brentuximab vedotin
1.2 mg/kg IV every 21 days
Other Names:
  • SGN-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Midazolam blood concentrations +/- brentuximab vedotin
Time Frame: 3 weeks
3 weeks
Brentuximab vedotin blood concentrations +/- rifampin
Time Frame: 6 weeks
6 weeks
Brentuximab vedotin in urine, feces, and blood
Time Frame: 1 week
1 week
Brentuximab vedotin blood concentrations in special populations
Time Frame: 3 weeks
3 weeks
Brentuximab vedotin blood concentrations +/- ketoconazole
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of adverse events and laboratory abnormalities
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

  • Study Director: Thomas Manley, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 2, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

December 18, 2014

Last Update Submitted That Met QC Criteria

December 17, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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