A Randomized, Phase 2 Study of Single-agent Erlotinib versus Oral Etoposide in Patients with Recurrent or Refractory Pediatric Ependymoma - PETEY

Phase 1

• Conditions: Recurrent or Refractory Paediatric Ependymoma; MedDRA version: 15.0 Level: PT Classification code 10014967 Term: Ependymoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-016836-11-GB
• Lead Sponsor: OSI Pharmaceuticals LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-26
• Study Completion: 2012-11-26
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Inclusion Criteria:
•Patients must have recurrent or refractory ependymoma or subependymoma and be >= 1 year to <= 21 years of age at the time of randomization/study entry;
•Performance status: Lansky >=50% for patients <=10 years of age; or Karnofsky 5>=0% for patients > 10 years of age; and
•Measurable disease.

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

Exclusion Criteria

Exclusion Criteria:
•Must not have previously received an EGFR-targeted therapy;
•Must not have previously received oral etoposide;
•Must not have received craniospinal radiotherapy within 24 weeks of randomization/study entry or involved field radiotherapy to the target lesion within 12 weeks of randomization/study entry; focal radiation to areas of symptomatic metastatic disease must not be given within 14 days

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified