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An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies


Phase 1
18 Years
N/A
Not Enrolling
Both
Disease, Hodgkin, Lymphoma, Large-Cell, Anaplastic, Lymphoma, Non-Hodgkin

Thank you

Trial Information

An Intensive QT/QTc Study to Investigate the Effects of SGN-35 (Brentuximab Vedotin) on Cardiac Ventricular Repolarization in Patients With CD30-Positive Malignancies


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

QTc interval

Outcome Time Frame:

2-4 days postdose

Safety Issue:

Yes

Principal Investigator

Naomi Hunder, MD

Investigator Role:

Study Director

Investigator Affiliation:

Seattle Genetics, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

SGN35-007

NCT ID:

NCT01026233

Start Date:

January 2010

Completion Date:

August 2011

Related Keywords:

  • Disease, Hodgkin
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Non-Hodgkin
  • Antibodies, Monoclonal
  • Antibody-Drug Conjugate
  • Antigens, CD30
  • Disease, Hodgkin
  • Drug Therapy
  • Hematologic Diseases
  • Immunotherapy
  • Lymphoma
  • monomethylauristatin E
  • Lymphoma, Large-Cell, Anaplastic
  • Hodgkin Disease
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Large-Cell, Anaplastic

Name

Location
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
City of Hope National Medical Center Los Angeles, California  91010
Baylor University Medical Center Dallas, Texas  75246
Stanford Cancer Center Stanford, California  94305-5824
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
New York University Cancer Institute New York, New York  10016
University of Miami Hospital and Clinics, Miller School of Medicine Miami, Florida  33136
Cardinal Bernardin Cancer Center / Loyola University Medical Center Maywood, Illinois  60153