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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01026233
Other study ID # SGN35-007
Secondary ID
Status Completed
Phase Phase 1
First received December 2, 2009
Last updated December 11, 2014
Start date January 2010
Est. completion date August 2011

Study information

Verified date December 2014
Source Seattle Genetics, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 52
Est. completion date August 2011
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
brentuximab vedotin
1.8 mg/kg IV every 21 days

Locations

Country Name City State
Germany University Hospital of Cologne Koln
United States University of Alabama at Birmingham Birmingham Alabama
United States Baylor University Medical Center Dallas Texas
United States City of Hope National Medical Center Duarte California
United States Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood Illinois
United States University of Miami Hospital and Clinics, Miller School of Medicine Miami Florida
United States New York University Cancer Institute New York New York
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Stanford Cancer Center Stanford California

Sponsors (2)

Lead Sponsor Collaborator
Seattle Genetics, Inc. Millennium Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

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 malignancie — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary QTc interval 2-4 days postdose Yes
Secondary ECG parameters 2-4 days postdose No
Secondary Blood MMAE levels Through 4 days postdose No
Secondary Incidence of proarrhythmic adverse events Through 1 month following last dose Yes
Secondary Incidence of adverse events and laboratory abnormalities Through 1 month following last dose Yes
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