Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

• Sponsor: Seagen Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01026233
• Collaborator: Millennium Pharmaceuticals, Inc. (Industry)
• Enrollment: 52
• Locations: 9
• Arm: 1
• Duration (Months): 19
• Patients Per Site: 5.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disease, Hodgkin; Lymphoma, Large-Cell, Anaplastic; Lymphoma, Non-Hodgkin	Drug: brentuximab vedotin	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 52 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 brentuximab vedotin	Drug: brentuximab vedotin; 1.8 mg/kg IV every 21 days; Other Names: SGN-35

Outcome Measures

Primary Outcome Measures

1. QTc interval [2-4 days postdose]

Secondary Outcome Measures

1. ECG parameters [2-4 days postdose]

2. Blood MMAE levels [Through 4 days postdose]

3. Incidence of proarrhythmic adverse events [Through 1 month following last dose]

4. Incidence of adverse events and laboratory abnormalities [Through 1 month following last dose]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35294-3300
2	City of Hope National Medical Center	Duarte	California	United States	91010
3	Stanford Cancer Center	Stanford	California	United States	94305
4	University of Miami Hospital and Clinics, Miller School of Medicine	Miami	Florida	United States	33136
5	Cardinal Bernardin Cancer Center / Loyola University Medical Center	Maywood	Illinois	United States	60153
6	New York University Cancer Institute	New York	New York	United States	10016
7	Fox Chase Cancer Center	Philadelphia	Pennsylvania	United States	19111
8	Baylor University Medical Center	Dallas	Texas	United States	75246
9	University Hospital of Cologne	Koln		Germany	50924

Sponsors and Collaborators

• Seagen Inc.
• Millennium Pharmaceuticals, Inc.

Investigators

• Study Director: Naomi Hunder, MD, Seagen Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Seagen Inc.
• ClinicalTrials.gov Identifier: NCT01026233
• Other Study ID Numbers: SGN35-007
• First Posted: Dec 4, 2009
• Last Update Posted: Dec 12, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Seagen Inc.: Antibodies, Monoclonal; Antibody-Drug Conjugate; Antigens, CD30; Disease, Hodgkin; Drug Therapy; Hematologic Diseases; Immunotherapy; Lymphoma; monomethylauristatin E; Lymphoma, Large-Cell, Anaplastic
• Additional relevant MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Large-Cell, Anaplastic; Hodgkin Disease; Brentuximab Vedotin

Study Results

No Results Posted as of Dec 12, 2014