Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

December 11, 2014 updated by: Seagen Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 1

Expanded Access

No longer available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Koln, Germany, 50924
        • University Hospital of Cologne
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294-3300
        • University of Alabama at Birmingham
    • California
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Stanford, California, United States, 94305
        • Stanford Cancer Center
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics, Miller School of Medicine
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Cardinal Bernardin Cancer Center / Loyola University Medical Center
    • New York
      • New York, New York, United States, 10016
        • New York University Cancer Institute
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
QTc interval
Time Frame: 2-4 days postdose
2-4 days postdose

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Millennium Pharmaceuticals, Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

December 2, 2009

First Submitted That Met QC Criteria

December 3, 2009

First Posted (Estimate)

December 4, 2009

Study Record Updates

Last Update Posted (Estimate)

December 12, 2014

Last Update Submitted That Met QC Criteria

December 11, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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