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Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

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ClinicalTrials.gov Identifier: NCT01026415
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 18, 2014
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Carcinomas Disease, Hodgkin Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Neoplasms 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  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012


Arm Intervention/treatment
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



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

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


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026415


Locations
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.
Investigators
Study Director: Thomas Manley, MD Seattle Genetics, Inc.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01026415     History of Changes
Other Study ID Numbers: SGN35-008
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: December 18, 2014
Last Verified: December 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
Immunotherapy
Hematologic Diseases
Lymphoma
Antibodies, Monoclonal

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Antibodies
Antibodies, Monoclonal
Midazolam
Ketoconazole
Rifampin
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
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents