Clinical trial NCT01026233: Cardiac Safety Study of Brentuximab Vedotin (SGN-35)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Disease, Hodgkin
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Keywords: Antibodies, Monoclonal
Antibody-Drug Conjugate
Antigens, CD30
Disease, Hodgkin
Drug Therapy
Hematologic Diseases
Immunotherapy
Lymphoma
monomethylauristatin E
Lymphoma, Large-Cell, Anaplastic
Lead sponsor: Seagen Inc.
Sponsor class: INDUSTRY
Collaborators: name: Millennium Pharmaceuticals, Inc.
First posted: 2009-12-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: QTc interval
timeFrame: 2-4 days postdose
Secondary outcomes:
measure: ECG parameters
timeFrame: 2-4 days postdose
measure: Blood MMAE levels
timeFrame: Through 4 days postdose
measure: Incidence of proarrhythmic adverse events
timeFrame: Through 1 month following last dose
measure: Incidence of adverse events and laboratory abnormalities
timeFrame: Through 1 month following last dose
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Stanford
country: United States
facility: Stanford Cancer Center
state: California
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Miller School of Medicine
state: Florida
city: Maywood
country: United States
facility: Cardinal Bernardin Cancer Center / Loyola University Medical Center
state: Illinois
city: New York
country: United States
facility: New York University Cancer Institute
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Koln
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: Seagen Inc.
name: Naomi Hunder, MD
role: STUDY_DIRECTOR
References:
citation: 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 malignancies. Cancer Chemother Pharmacol. 2013 Jul;72(1):241-9. doi: 10.1007/s00280-013-2192-z. Epub 2013 May 30.
citation: Rothe A, Sasse S, Goergen H, Eichenauer DA, Lohri A, Jager U, Bangard C, Boll 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.
citation: Gopal AK, Ramchandren R, O'Connor OA, Berryman RB, Advani RH, Chen R, Smith SE, Cooper M, Rothe A, Matous JV, Grove LE, Zain J. Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation. Blood. 2012 Jul 19;120(3):560-8. doi: 10.1182/blood-2011-12-397893. Epub 2012 Apr 17.