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Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

This study has been completed.
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc. Identifier:
First received: December 2, 2009
Last updated: December 17, 2014
Last verified: December 2014
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).

Condition Intervention Phase
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Drug: brentuximab vedotin
Drug: rifampin
Drug: midazolam
Drug: ketoconazole
Phase 1

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Seattle Genetics, Inc.:

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

Secondary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: 6 weeks ]

Enrollment: 73
Study Start Date: December 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
midazolam +/- brentuximab vedotin
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Name: ADCETRIS; SGN-35
Drug: midazolam
1 mg IV
Experimental: 2
brentuximab vedotin +/- rifampin
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Name: ADCETRIS; SGN-35
Drug: rifampin
600 mg/day PO
Experimental: 3
brentuximab vedotin +/- ketoconazole
Drug: ketoconazole
400 mg/day PO
Drug: brentuximab vedotin
1.2 mg/kg IV every 21 days
Other Name: SGN-35
Experimental: 4
special populations
Drug: brentuximab vedotin
1.2 mg/kg IV every 21 days
Other Name: SGN-35


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01026415

United States, California
City of Hope
Duarte, California, United States, 91010
United States, Colorado
Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
United States, Indiana
St. Francis Medical Group Oncology & Hematology Specialists
Indianapolis, Indiana, United States, 46237
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48209
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, Washington
Seattle Cancer Care Alliance / University of Washington Medical Center
Seattle, Washington, United States, 98109-1023
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Thomas Manley, MD Seattle Genetics, Inc.
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc. Identifier: NCT01026415     History of Changes
Other Study ID Numbers: SGN35-008
Study First Received: December 2, 2009
Last Updated: December 17, 2014

Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antigens, CD30
Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
monomethyl auristatin E
Drug Therapy
Hematologic Diseases
Antibodies, Monoclonal

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents processed this record on April 28, 2017