Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

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

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).

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