Clinical Pharmacology Study of Brentuximab Vedotin (SGN-35)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seagen Inc.; Seattle Genetics, Inc.
• Collaborator: Millennium Pharmaceuticals, Inc.
• Treatments: Antibodies; Antibodies, Monoclonal; Brentuximab Vedotin; Ketoconazole; Midazolam; Rifampin

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