Overview

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