Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

• Status: Completed
• Trial end date: 2011-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate cardiac safety of brentuximab vedotin (SGN-35) in patients with CD30-positive cancers. The study will assess electrical activity of the heart before and after brentuximab vedotin administration. Patients who have stable or improving disease may receive up to 1 year of brentuximab vedotin treatment.

• 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

Criteria

Inclusion Criteria:

• Relapsed or refractory CD30-positive malignancy

• Adequate organ function

• ECOG performance status <2

Exclusion Criteria:

• Cardiac abnormalities (abnormal rhythm, history of significant cardiac event)

• Current diagnosis of primary cutaneous ALCL

• Acute or chronic graft-versus-host disease

• Prior hematopoietic stem cell transplant within specified timeframe