drugset / Trial / NCT01032070

Erlotinib Versus Oral Etoposide in Patients With Recurrent or Refractory Pediatric Ependymoma

NCT01032070 ↗

Phase 2 Terminated 25 enrolled OSI Pharmaceuticals
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

EvaluationDrugModalityDoseRoute
Subject Erlotinib Small molecule 85 mg/m2 Oral
Comparator Etoposide Small molecule 50 mg/m2 Oral

Indications