Open-label, Phase 2 Study of Single-agent Erlotinib for Patients with Pediatric Ependymoma Previously Treated with Oral Etoposide in Protocol OSI-774-205 - Erlotinib in paediatric ependymoma patients previously treated with etoposide
- Conditions
- Recurrent or Refractory EpendymomaMedDRA version: 15.0Level: PTClassification code 10014967Term: EpendymomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-023478-38-GB
- Lead Sponsor
- OSI Pharmaceuticals LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 4
Patients must meet all of the following inclusion criteria to be eligible for participation in this study:
•Patients must have been enrolled in OSI-774-205, been randomized to oral etoposide and either progressed (according to study criteria) while on study or discontinued due to unacceptable toxicity related to etoposide;
•Performance status: Lansky greater than or equal to 50% for patients not more than (NMT) 10 years of age or Karnofsky greater than or equal to 50% for patients > 10 years of age;
•Patients must have recovered from any acute toxicity to any prior anti-cancer treatment;
•Total bilirubinNMT 1.5 x upper limit of normal for age, SGPT (ALT) NMT 3 x ULN;
•Serum creatinine based on age OR Creatinine Clearance/GFR greater than or equal to 70 mL/min/m2;
Age (Years)Serum Creatinine (mg/dL)
Less than 5 NMT 0.8
5 < age NMT 10 NMT 1.0
10 < age NMT 15 NMT 1.2
> 15 NMT 1.5
•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; and
•Patients must be able to swallow whole or crushed tablets.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Patients who meet any of the following exclusion criteria are not eligible for this study:
•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; and/or
•Pregnant or breast-feeding.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess the safety profile of single-agent erlotinib in patients with recurrent or refractory pediatric ependymoma who were previously treated with oral etoposide in Protocol OSI-774-205.;Secondary Objective: The secondary objectives of this study are to evaluate:<br>•Best disease response as determined by the investigator per institutional standards; and<br>•The median treatment duration for patients receiving erlotinib in this clinical setting.<br>;Primary end point(s): Safety assessed via physical examination, vital signs, clinical laboratory tests, and adverse events.<br><br>
- Secondary Outcome Measures
Name Time Method