Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

Completed · Phase 1

Conditions studied: Carcinomas, Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin, Neoplasms

In brief

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).

Key facts

Study ID

NCT01026415

Run by

Seagen Inc.

People needed

73

Starts

2009-12-01

Expected to finish

2012-05-01

Last updated by the study team

2014-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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