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

Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol in Combination With Carboplatin Versus Carboplatin With Placebo in Patients With Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: MEI Pharma, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fallopian Tube Cancer
• Peritoneal Neoplasms
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	phenoxodiol	400mg phenoxodiol three times daily in 28 day cycles.
DRUG	carboplatin	AUC=2 weekly in 28 day cycles
DRUG	placebo	every 8 hours daily in 28 day cycles

Timeline

• Start date: 2006-10-01
• Primary completion: 2009-04-01
• Completion: 2011-04-01
• First posted: 2006-10-02
• Last updated: 2016-07-18

Locations

70 sites across 7 countries: United States, Australia, Belgium, Italy, Poland, Spain, United Kingdom