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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

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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 CenterPhiladelphia, Pennsylvania  19111
City of Hope National Medical CenterLos Angeles, California  91010
Baylor University Medical CenterDallas, Texas  75246
Stanford Cancer CenterStanford, California  94305-5824
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
New York University Cancer InstituteNew York, New York  10016
University of Miami Hospital and Clinics, Miller School of MedicineMiami, Florida  33136
Cardinal Bernardin Cancer Center / Loyola University Medical CenterMaywood, Illinois  60153