drugset / Trial / NCT01032070
Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a phase 2 study to evaluate the efficacy of single-agent erlotinib versus oral etoposide in patients with recurrent or refractory pediatric ependymoma.
Timeline
- Start
- 2010-09-27
- Primary completion
- 2012-11-26
- Completion
- 2012-11-26
Outcome
Missed primary endpoint
Stopped: “In a pre-planned interim analysis, OSI-774-205 met futility for efficacy with no safety concerns. As a result, it has been stopped.”
registry analysis (unspecified test); Erlotinib vs Etoposide; p = 0.2200; Fisher Exact NCT01032070 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Erlotinib | Small molecule | 85 mg/m2 | Oral |
| Comparator | Etoposide | Small molecule | 50 mg/m2 | Oral |