Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Lymphoma, Non-Hodgkin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026233
• Other study ID #: SGN35-007
• Status: Completed
• Phase: Phase 1
• First received: December 2, 2009
• Last updated: December 11, 2014
• Start date: January 2010
• Est. completion date: August 2011

Study information

• Verified date: December 2014
• Source: Seattle Genetics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: August 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• brentuximab vedotin
1.8 mg/kg IV every 21 days

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Genetics, Inc.	Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

Han TH, Chen R, Advani R, Berryman RB, Smith SE, Forero-Torres A, Rosenblatt JD, Smith MR, Zain J, Hunder NN, Engert A. Brentuximab vedotin does not cause clinically relevant QTc interval prolongation in patients with CD30-positive hematologic malignancie — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	QTc interval		2-4 days postdose	Yes
Secondary	ECG parameters		2-4 days postdose	No
Secondary	Blood MMAE levels		Through 4 days postdose	No
Secondary	Incidence of proarrhythmic adverse events		Through 1 month following last dose	Yes
Secondary	Incidence of adverse events and laboratory abnormalities		Through 1 month following last dose	Yes