NCT01026233

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Seagen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disease, Hodgkin
• Lymphoma, Large-Cell, Anaplastic
• Lymphoma, Non-Hodgkin

Interventions

Type	Name	Description
DRUG	brentuximab vedotin	1.8 mg/kg IV every 21 days

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-08-01
• Completion: 2011-08-01
• First posted: 2009-12-04
• Last updated: 2014-12-12

Locations

9 sites across 2 countries: United States, Germany