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Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

This study has been completed.
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01026233
First received: December 2, 2009
Last updated: October 7, 2011
Last verified: October 2011
History of Changes

December 2, 2009
October 7, 2011
January 2010
August 2010   (final data collection date for primary outcome measure)
QTc interval [ Time Frame: 2-4 days postdose ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01026233 on ClinicalTrials.gov Archive Site
  • ECG parameters [ Time Frame: 2-4 days postdose ] [ Designated as safety issue: No ]
  • Blood MMAE levels [ Time Frame: Through 4 days postdose ] [ Designated as safety issue: No ]
  • Incidence of proarrhythmic adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Cardiac Safety Study of Brentuximab Vedotin (SGN-35)
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
Drug: brentuximab vedotin
1.8 mg/kg IV every 21 days
Other Name: SGN-35
Experimental: 1
brentuximab vedotin
Intervention: Drug: brentuximab vedotin
Rothe A, Sasse S, Goergen H, Eichenauer DA, Lohri A, Jäger U, Bangard C, Böll B, von Bergwelt Baildon M, Theurich S, Borchmann P, Engert A. Brentuximab vedotin for relapsed or refractory CD30+ hematologic malignancies: the German Hodgkin Study Group experience. Blood. 2012 Aug 16;120(7):1470-2. doi: 10.1182/blood-2012-05-430918. Epub 2012 Jul 11.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
52
August 2011
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT01026233
SGN35-007
No
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Study Director: Naomi Hunder, MD Seattle Genetics, Inc.
Seattle Genetics, Inc.
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP