Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies

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.

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