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Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Primary Purpose

Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
brentuximab vedotin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disease, Hodgkin focused on measuring Antibodies, Monoclonal, Antibody-Drug Conjugate, Antigens, CD30, Disease, Hodgkin, Drug Therapy, Hematologic Diseases, Immunotherapy, Lymphoma, monomethylauristatin E, Lymphoma, Large-Cell, Anaplastic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope National Medical Center
  • Stanford Cancer Center
  • University of Miami Hospital and Clinics, Miller School of Medicine
  • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • New York University Cancer Institute
  • Fox Chase Cancer Center
  • Baylor University Medical Center
  • University Hospital of Cologne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

brentuximab vedotin

Outcomes

Primary Outcome Measures

QTc interval

Secondary Outcome Measures

ECG parameters
Blood MMAE levels
Incidence of proarrhythmic adverse events
Incidence of adverse events and laboratory abnormalities

Full Information

First Posted
December 2, 2009
Last Updated
December 11, 2014
Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01026233
Brief Title
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

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
brentuximab vedotin
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
SGN-35
Intervention Description
1.8 mg/kg IV every 21 days
Primary Outcome Measure Information:
Title
QTc interval
Time Frame
2-4 days postdose
Secondary Outcome Measure Information:
Title
ECG parameters
Time Frame
2-4 days postdose
Title
Blood MMAE levels
Time Frame
Through 4 days postdose
Title
Incidence of proarrhythmic adverse events
Time Frame
Through 1 month following last dose
Title
Incidence of adverse events and laboratory abnormalities
Time Frame
Through 1 month following last dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naomi Hunder, MD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Miami Hospital and Clinics, Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cardinal Bernardin Cancer Center / Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
New York University Cancer Institute
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Baylor University Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University Hospital of Cologne
City
Koln
ZIP/Postal Code
50924
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
23719719
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.
Results Reference
result
PubMed Identifier
22786877
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. Erratum In: Blood. 2014 Aug 14;124(7):1201.
Results Reference
derived
PubMed Identifier
22510871
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.
Results Reference
derived

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Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

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