ActivePhase 3ACTRN12606000471583

OVATURE (OVArian TUmor REsponse) study

Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol (Oral Dosage Form) 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

Sponsor

Marshall Edwards Pty Ltd

Enrollment

340 participants

Start Date

Oct 20, 2006

Study Type

Interventional

Conditions

Epithelial ovarian, fallopian or primary peritoneal cancer that is resistant or refractory to 2-weekly, 3- or 4-weekly platinum drug therapy

Summary

The OVATURE study will compare the investigational drug Phenoxodiol combined with the chemotherapy drug Carboplatin against a placebo combined with Carboplatin. It is hypothesised that Phenoxodiol will reverse chemo-resistance to platinum drugs in late stage ovarian, fallopian and primary peritoneal cancers. For more information on the study and sponsor go to http://www.marshalledwardsinc.com/ or www.phenoxodiol.com

Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking at: OVATURE (OVArian TUmor REsponse) study. It is open to women only, aged 18 and older. To take part, you generally need: histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin. There are also some health conditions and factors that may prevent you from joining.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Intervention group The Phenoxodiol oral dose will be 2x200mg capsules taken 8 hourly (three times per day). Patients will receive carboplatin at a dosage of (Area Under the Curve) AUC=2, administered

Intervention group The Phenoxodiol oral dose will be 2x200mg capsules taken 8 hourly (three times per day). Patients will receive carboplatin at a dosage of (Area Under the Curve) AUC=2, administered by intravenous injection once a week. Carboplatin will be administered weekly as a change in regimen from 3-weekly to weekly has been shown with taxanes to provide tumor response in patients whose tumors have become resistant to a 3-weekly regimen. The OVATURE study will compare Phenoxodiol (in the oral dosage form) combined with Carboplatin against Placebo combined with Carboplatin. The duration of each treatment cycle will be 4 weeks and there is no limit to the number of treatment cycles that can be administered. The expected overall trial completion date is March 2010. Treatment cycles will be discontinued in the case of unacceptable toxicity, disease progression, patient voluntary withdrawal, or if the Investigator or Sponsor asks for the patient to be withdrawn.

Locations(5)

TX, CA, NJ, KS, CT, TN, UT, OH, VA, NV, GA, MI, NC, NY, NM, AZ, LA, United States of America

Leuven, Edegam, Belgium

Gdansk, Bialystok, Krakow, Warszawa, Gliwice, Poznan,, Poland

Glasgow, Wirral, Birmingham, Edinburgh, London, Nottingham, Sutton, Leeds, Somerset, Dundee,, United Kingdom

Barcelona, Alincante, Valencia,, Spain

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ACTRN12606000471583