Status:
TERMINATED
Single-agent Erlotinib in Patients Previously Treated With Oral Etoposide in Protocol OSI-774-205
Lead Sponsor:
OSI Pharmaceuticals
Conditions:
Ependymoma
Eligibility:
All Genders
1-21 years
Phase:
PHASE2
Brief Summary
Participants that were assigned to the oral etoposide treatment arm in protocol OSI-774-205 and either progressed while on study or discontinued due to unacceptable toxicity related to etoposide were ...
Detailed Description
The protocol-specified futility criteria were met at the second interim analysis dated 15 Aug 2012 for OSI-774-205. Per the Data Monitoring Committee's recommendation and FDA's agreement, the enrollme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 23 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 13 2012
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT01247922
Start Date
May 23 2011
End Date
September 13 2012
Last Update
December 6 2024
Active Locations (21)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Children's Hospital of Orange County (CHOC)
Orange, California, United States, 92868
3
Packard Children's Hospital
Palo Alto, California, United States, 94304
4
The Children's Hospital Center for Cancer and Blood Disorders
Aurora, Colorado, United States, 80045