Text Size

Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01026415
First received: December 2, 2009
Last updated: May 30, 2013
Last verified: May 2013
History of Changes
  Purpose

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

An investigational treatment associated with this study has been approved for sale to the public.   More info ...

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
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:

U.S. FDA Resources

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

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

Secondary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: December 2009
Estimated Study Completion Date: December 2013
Primary Completion Date: August 2011 (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: 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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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, 48201
United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
NYU Clinical Cancer Center
New York, New York, United States, 10016
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: Laurie Grove, PA-C Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01026415     History of Changes
Other Study ID Numbers: SGN35-008
Study First Received: December 2, 2009
Last Updated: May 30, 2013
Health Authority: United States: Food and Drug Administration

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:
Neoplasms
Carcinoma
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Large-Cell, Anaplastic
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, B-Cell
Lymphoma, T-Cell
 Antibodies, Monoclonal
Midazolam
Ketoconazole
Rifampin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on June 18, 2013