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Open-label, Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205

Phase 2
1 Year
21 Years
Not Enrolling

Thank you

Trial Information

Open-label, Phase 2 Study of Single-agent Erlotinib for Patients With Pediatric Ependymoma Previously Treated With Oral Etoposide in Protocol OSI-774-205

Inclusion Criteria:

- Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide
and either progressed while on study or discontinued due to unacceptable toxicity
related to etoposide

- Performance status: Lansky ≥ 50% for patients ≤ 10 years of age or younger or
Karnofsky ≥ 50% for patients greater than 10 years of age

- Patients must have recovered from any acute toxicity to any prior anti-cancer

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, serum glutamic pyruvic
transaminase (SGPT) ALT ≤ 3 x ULN

- Serum creatinine based on age OR Creatinine Clearance/Glomerular Filtration Rate
(GFR) ≥ 70 mL/min/m2

- Patients must be neurologically stable for at least 7 days before registration

- Patients, both males and females, with reproductive potential must agree to practice
effective contraceptive measures for the duration of study drug therapy and for at
least 90 days after completion of study drug therapy

- Patients must be able to take erlotinib orally

Exclusion Criteria:

- Taking strong/moderate CYP3A4 or CYP1A2 inhibitors/inducers ≤ 14 days before

- Have received any other chemotherapy or immunotherapy to treat ependymoma after
discontinuation from OSI-774-205

- Taking proton pump inhibitors ≤ 14 days before registration

- Participating in another investigational drug trial while on study

- Pregnant or breast-feeding

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assess safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma previously treated with oral etoposide

Outcome Time Frame:

An average of 4 months

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

September 2012

Related Keywords:

  • Ependymoma
  • Pediatric Ependymoma
  • Ependymoma
  • Erlotinib
  • Tarceva
  • Ependymoma



University of Alabama at Birmingham Birmingham, Alabama  35294-3300
University of Miami Miami, Florida  33136
University of Wisconsin Madison,, Wisconsin  53792-5666
Children's Hospital of Orange County (CHOC) Orange, California  92868
Packard Children's Hospital Palo Alto, California  94304
The Children's Hospital Center 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 University Children's Healthcare of Atlanta Atlanta, Georgia  30322
University of Minnesota - Amplatz Children's Hospital Minneapolis, Minnesota  55455
Oregon Health & Sciences University Doernbecher Children's Hospital Portland, Oregon  97124
Childrens Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania  15224