Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Completed · Phase 1

Conditions studied: Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

In brief

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.

Key facts

Study ID: NCT01026233
Run by: Seagen Inc.
People needed: 52
Starts: 2010-01-01
Expected to finish: 2011-08-01
Last updated by the study team: 2014-12-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Relapsed or refractory CD30-positive malignancy
Adequate organ function
ECOG performance status <2

You may not qualify if…

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

Where it is running

University of Alabama at Birmingham — Birmingham, Alabama, United States
City of Hope National Medical Center — Duarte, California, United States
Stanford Cancer Center — Stanford, California, United States
University of Miami Hospital and Clinics, Miller School of Medicine — Miami, Florida, United States
Cardinal Bernardin Cancer Center / Loyola University Medical Center — Maywood, Illinois, United States
New York University Cancer Institute — New York, New York, United States
Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
Baylor University Medical Center — Dallas, Texas, United States
University Hospital of Cologne — Cologne, Germany

Full record on ClinicalTrials.gov

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