drugset / Trial / NCT00382811

OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer

NCT00382811 ↗

Phase 3 Completed 142 enrolled MEI Pharma, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in combination with weekly carboplatin, is effective against late stage ovarian cancer and to see what, if any, side-effects of treatment may result.

Timeline

Start
2006-10
Primary completion
2009-04
Completion
2011-04

Outcome

Missed primary endpoint

paper PFS for group 1 was 15.4 weeks [95% confidence interval (CI) 11.1-21.0] versus 20.1 weeks for group 2 (95% CI = 13.1-33.4); P = 0.3. PMID 24318743 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject idronoxil Small molecule 400 mg Oral
Background Carboplatin Small molecule 2 unknown —