Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Phase 1

Completed

• Conditions: Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin; Disease, Hodgkin
• Interventions: Drug: brentuximab vedotin

• Registration Number: NCT01026233
• Lead Sponsor: Seagen Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-03
• Study First Posted: 2009-12-04
• Study Start: 2010-01
• Primary Completion: 2010-08
• Study Completion: 2011-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-11
• Last Update Posted: 2014-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	brentuximab vedotin	brentuximab vedotin

Primary Outcome Measures

Name	Time	Method
QTc interval	2-4 days postdose

Secondary Outcome Measures

Name	Time	Method
Blood MMAE levels	Through 4 days postdose
ECG parameters	2-4 days postdose
Incidence of proarrhythmic adverse events	Through 1 month following last dose
Incidence of adverse events and laboratory abnormalities	Through 1 month following last dose

Trial Locations

Locations (9)

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

City of Hope National Medical Center; 🇺🇸 Duarte, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Miami Hospital and Clinics, Miller School of Medicine; 🇺🇸 Miami, Florida, United States

Stanford Cancer Center; 🇺🇸 Stanford, California, 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

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

University Hospital of Cologne; 🇩🇪 Koln, Germany