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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


Phase 1
18 Years
N/A
Open (Enrolling by invite only)
Both
Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Midazolam blood concentrations +/- brentuximab vedotin

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

Laurie Grove, PA-C

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-008

NCT ID:

NCT01026415

Start Date:

December 2009

Completion Date:

December 2013

Related Keywords:

  • Carcinomas
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Neoplasms
  • 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
  • Neoplasms
  • Carcinoma
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic

Name

Location
Hackensack University Medical Center Hackensack, New Jersey  07601
City of Hope Duarte, California  91010
NYU Clinical Cancer Center New York, New York  10016
Colorado Blood Cancer Institute Denver, Colorado  80218
Karmanos Cancer Institute / Wayne State University Detroit, Michigan  48201
St. Francis Medical Group Oncology & Hematology Specialists Indianapolis, Indiana  46237
Seattle Cancer Care Alliance / University of Washington Medical Center Seattle, Washington  98109