NCT00382811: OVATURE

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

Completed Phase 3 Last updated 13 July 2016

What this trial tests

Phase 3 trial testing phenoxodiol in Fallopian Tube Cancer in 142 participants. Completed in 1 April 2011.

Timeline

1 October 2006

Primary endpoint
1 April 2009

1 April 2011

Quick facts

Lead sponsor	MEI Pharma, Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	142
Start date	1 October 2006
Primary completion	1 April 2009
Estimated completion	1 April 2011
Sites	70 locations across United States, Australia, Belgium, Italy, Poland, Spain, United Kingdom

Drugs / interventions tested

• phenoxodiol — full drug profile →
• carboplatin (Carboplatin) — full drug profile →
• placebo

Conditions studied

• Fallopian Tube Cancer — all drugs for Fallopian Tube Cancer →
• Peritoneal Neoplasms — all drugs for Peritoneal Neoplasms →
• Ovarian Cancer — all drugs for Ovarian Cancer →

Sponsor

MEI Pharma, Inc. — full company profile →

Who can join

18 and older, female only, with Fallopian Tube Cancer or Peritoneal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
  Time frame: Progression Free Survival

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Phytochemical-Based Nanomedicine for Advanced Cancer Theranostics: Perspectives on Clinical Trials to Clinical Use.
   Dhupal M, Chowdhury D. · · 2020 · cited 48× · PMID 33244231 · DOI 10.2147/ijn.s259628
2. Targeting tumor ubiquitin-proteasome pathway with polyphenols for chemosensitization.
   Shen M, Chan TH, Dou QP. · · 2012 · cited 41× · PMID 22292765 · DOI 10.2174/187152012802649978
3. Recent updates on nano-phyto-formulations based therapeutic intervention for cancer treatment.
   Wahi A, Bishnoi M, Raina N, Singh MA, et al · · 2023 · cited 20× · PMID 38188681 · DOI 10.32604/or.2023.042228
4. Synthesis of Dextran-Phenoxodiol and Evaluation of Its Physical Stability and Biological Activity.
   Yee EMH, Cirillo G, Brandl MB, Black DS, et al · · 2019 · cited 10× · PMID 31440502 · DOI 10.3389/fbioe.2019.00183
5. A first-in-human dose-escalation study of ME-143, a second generation NADH oxidase inhibitor, in patients with advanced solid tumors.
   Pant S, Burris HA, Moore K, Bendell JC, et al · · 2014 · cited 7× · PMID 23525756 · DOI 10.1007/s10637-013-9949-4
6. Investigations of Electronic, Structural, and In Silico Anticancer Potential of Persuasive Phytoestrogenic Isoflavene-Based Mannich Bases.
   Mutahir S, Khan MA, Mushtaq M, Deng H, et al · · 2023 · cited 3× · PMID 37570881 · DOI 10.3390/molecules28155911