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Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

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ClinicalTrials.gov Identifier: NCT01026233
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : December 12, 2014
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, 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.

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

Access to an investigational treatment associated with this study is available outside the clinical trial.   More info ...

Study Type : Interventional  (Clinical Trial)
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 : January 2010
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2011


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



Primary Outcome Measures :
  1. QTc interval [ Time Frame: 2-4 days postdose ]

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


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026233


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
City of Hope National Medical Center
Duarte, California, United States, 91010
Stanford Cancer Center
Stanford, California, United States, 94305
United States, Florida
University of Miami Hospital and Clinics, Miller School of Medicine
Miami, Florida, United States, 33136
United States, Illinois
Cardinal Bernardin Cancer Center / Loyola University Medical Center
Maywood, Illinois, United States, 60153
United States, New York
New York University Cancer Institute
New York, New York, United States, 10016
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Texas
Baylor University Medical Center
Dallas, Texas, United States, 75246
Germany
University Hospital of Cologne
Koln, Germany, 50924
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.

Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01026233     History of Changes
Other Study ID Numbers: SGN35-007
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Seattle Genetics, 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
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs