A Randomized, Phase 2 Study of Single-agent Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
This is a phase 2 study involving a 1:1 randomization of 40 patients with recurrent or
refractory pediatric ependymoma who will receive either erlotinib or oral etoposide.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
The proportion of patients with a best overall response of complete response or partial response
At end of study (up to 12 months)
No
Medical Monitor
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
OSI-774-205
NCT01032070
December 2009
November 2012
Name | Location |
---|---|
Children's Hospital of Pittsburgh of UPMC | Pittsburgh, Pennsylvania 15213 |
University of Miami | Miami, Florida 33136 |
Penn State Hershey Children's Hospital | Hershey, Pennsylvania 17033 |
University of Alabama at Birminghamn Dept. of Pediatric-Hematology/Oncology | Birmingham, Alabama 35233 |
Center for Cancer and Blood Disorders-Phoenix Children's Hospital | Phoenix, Arizona 85016 |
Children's Hospital of Orange County (CHOC) | Orange, California 92868 |
Stanford University and Lucile Packard Children's Hospital | Palo Alto, California 94304 |
Children's HospitalCenter for Cancer and Blood Disorders | Aurora, Colorado 80045 |
Children's National Medical Center - D.C. Center for Cancer and Blood Disorders | Washington, District of Columbia 20010 |
Emory UniversityChildren's Healthcare of AtlantaAflac Cancer Center & Blood Disorders | Atlanta, Georgia 30322 |
Johns Hopkins UniversitySchool of Medicine | Baltimore, Maryland 21287 |
Dana-Farber Cancer Institute Department of Pediatric Neuro-oncology | Boston, Massachusetts 02115 |
Amplatz Children's Hospital Univeristy of Minnesota Medical Center- Pediatric Hematology Oncology | Minneapolis, Minnesota 55455 |
Columbia University Children's Hospital of New York Presbyterian Child & Adolescent Oncology Center | New York, New York 10032 |
Steven D Hassenfeld Children's Center - New York University | New York, New York 10016 |
Oregon Health & Sciences UniversityDoembecher Children's Hospital | Portland, Oregon 97124 |
Children's Medical Center, Dallas Center for Cancer and Blood Disorders | Dallas, Texas 75235 |
University of WisconsinPediatric Hematology/Oncology Department | Madison, Wisconsin 53705-2275 |