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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
Both
Ependymoma

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
treatment

- 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
registration

- 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:

Interventional

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:

No

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Astellas Pharma Global Development

Authority:

United States: Food and Drug Administration

Study ID:

OSI-774-206

NCT ID:

NCT01247922

Start Date:

April 2011

Completion Date:

September 2012

Related Keywords:

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

Name

Location

University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of MiamiMiami, Florida  33136
University of WisconsinMadison,, Wisconsin  53792-5666
Children's Hospital of Orange County (CHOC)Orange, California  92868
Packard Children's HospitalPalo Alto, California  94304
The Children's Hospital Center for Cancer and Blood DisordersAurora, Colorado  80045
Children's National Medical Center -D.C. Center for Cancer and Blood DisordersWashington, District of Columbia  20010
Emory University Children's Healthcare of AtlantaAtlanta, Georgia  30322
University of Minnesota - Amplatz Children's HospitalMinneapolis, Minnesota  55455
Oregon Health & Sciences University Doernbecher Children's HospitalPortland, Oregon  97124
Childrens Hospital of Pittsburgh of UPMCPittsburgh, Pennsylvania  15224