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

NCT01026415 Phase 1 COMPLETED

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).

Details

Lead sponsor	Seagen Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	73
Start date	2009-12
Completion	2012-05

Conditions

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

Interventions

• brentuximab vedotin
• rifampin
• midazolam
• ketoconazole
• brentuximab vedotin

Primary outcomes

• Midazolam blood concentrations +/- brentuximab vedotin — 3 weeks
• Brentuximab vedotin blood concentrations +/- rifampin — 6 weeks
• Brentuximab vedotin in urine, feces, and blood — 1 week
• Brentuximab vedotin blood concentrations in special populations — 3 weeks
• Brentuximab vedotin blood concentrations +/- ketoconazole — 6 weeks

Countries

United States