Clinical TrialID 2545

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

Fallopian Tube Cancer|Peritoneal Neoplasms|Ovarian Cancer

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Record Fields

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Clinical Trial Id
2545
Evidence Id
2545
Core Evidence Id
2545
Source Clinical Trial Id
2525
Herb2 Clinical Trial Id
HBCT002525
Nct Id
NCT00382811
Title
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Status
Completed
Phase
Phase 3
Study Result
No
Study Condition
Fallopian Tube Cancer|Peritoneal Neoplasms|Ovarian Cancer
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Intervention
DRUG: phenoxodiol|DRUG: carboplatin|DRUG: placebo
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Quadruple
Intervention Purpose
Treatment
Gender
Female
Age
Adult, Older_Adult
Enrollment
142
Outcome Measure
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death, Progression Free Survival
Sponsor Collaborator
MEI Pharma, Inc.
Funded By
INDUSTRY
Location
Arizona Clinical Research Center, Inc., Tuscon, Arizona, 85715, United States|Glendale Adventist, Glendale, California, 91206, United States|Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, 90027, United States|Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|Gynecology Oncology Associates, Newport Beach, California, 92663, United States|Yale University School of Medicine, New Haven, Connecticut, 06520, United States|Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center), Stamford, Connecticut, 06902, United States|Gynecologic Oncology Associates, Pembroke Pines, Florida, 33028, United States|Piedmont Hospital, Atlanta, Georgia, 30309, United States|Medical College of Georgia Cancer Center, Augusta, Georgia, 30912, United States|Associates in Women's Health, Wichita, Kansas, 67214, United States|Hematology and Oncology Specialists, LLC, Metairie, Louisiana, 70006, United States|Greater Baltimore Medical Centre, Baltimore, Maryland, 21204, United States|Gynecologic Oncology of West Michigan, Grand Rapids, Michigan, 49546, United States|Providence Hospital and Medical Centers, Southfield, Michigan, 48075, United States|The Center for Cancer & Hematological Disease, Cherry Hill, New Jersey, 08003, United States|Jersey Shore Medical Center, Neptune, New Jersey, 07754, United States|The University of New Mexico Cancer Research and Treatment Center, Albuquerque, New Mexico, 87131-0001, United States|Schwartz Gynecologic Oncology, Brightwaters, New York, 11718, United States|New York Downtown Hospital, New York, New York, 10038, United States|University of Rochester Gynecologic Oncology Associates, Rochester, New York, 14620, United States|Carolinas Medical Center, Charlotte, North Carolina, 28204, United States|Brody School of Medical at East Carolina University, Greenville, North Carolina, 27834, United States|Wake Forest University Health Sciences, Winston-Salem, North Carolina, 27157, United States|Gabrail Cancer Center, Canton, Ohio, 44718, United States|MetroHealth Medical Center, Cleveland, Ohio, 44109, United States|OSU James Cancer Hospital & Solove Research Institute, Columbus, Ohio, 43210, United States|Miami Valley Hospital, Dayton, Ohio, United States|Chattanooga GYN Oncology, Chattanooga, Tennessee, 37403, United States|Chattanooga's Program In Women's Oncology, Chattanooga, Tennessee, 37403, United States|Hall and Martin MDS, P.C., Knoxville, Tennessee, 37920, United States|Sarah Cannon Research Institute, Nashville, Tennessee, 37203, United States|Hope Cancer Clinic, Brownsville, Texas, 78526, United States|University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center, Dallas, Texas, 75390, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|Northern Virginia Pelvic Surgery Associates, Annadale, Virginia, 22003, United States|Virginia Mason Medical Center Department of Hematology/Oncology, Seattle, Washington, 98101, United States|Prince of Wales Hospital, Randwick, New South Wales, Australia|Royal North Shore Hospital, Sydney, New South Wales, 2065, Australia|Westmead Hospital, Westmead, New South Wales, Australia|Mater Adult Hospital, Brisbane, Queensland, Australia|Royal Adelaide Hospital, Adelaide, South Australia, Australia|UZ Antwerpen, Edegem, 2650, Belgium|UZ Leuven, Leuven, 3000, Belgium|IEO- Istituto Europeo di Oncologia, Milano, 20141, Italy|Istitutio Fisioterapici Ospitaleri, Roma, 00144, Italy|Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej, Bialystok, 15-027, Poland|Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku, Gdansk, 80-402, Poland|Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach, Gliwice, 44-101, Poland|Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej, Krakow, 31-115, Poland|Centrum Onkologii Ziemi, Lublin, 20-090, Poland|Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej, Poznan, 60-535, Poland|Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych, Warszawa, 02-781, Poland|Hospital Germans Trias i Pujol, Badalona, Barcelona, 08916, Spain|Hospital General Universitario de Alicante, Alicante, 03010, Spain|Hospital del Mar, Barcelona, 08003, Spain|Hospital General Vall d'Hebron, Barcelona, 08035, Spain|Hospital Clinic i Provincial de Barcelona, Barcelona, 08036, Spain|Hospital General Universitario de Valencia, Valencia, 46014, Spain|Yeovil District Hospital, Yeovil, Somerset, BA21 4AT, United Kingdom|Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building, Birmingham, B18 7QH, United Kingdom|Ninewells Hospital, Dundee, DD1 9SY, United Kingdom|Edinburgh Cancer Research Centre Western General Hospital, Edinburgh, EH4 2XR, United Kingdom|The Beatson West of Scotland Cancer Centre, Glasgow, G12 0YH, United Kingdom|St James University Hospital, Leeds, LS9 7TF, United Kingdom|Hammersmith Hospital, London, W12 0HS, United Kingdom|Cancer Research UK & UCL Cancer Trials Center, London, W1T 4TJ, United Kingdom|Nottingham University Hospitals NHS Trust, Nottingham, NG5 1PB, United Kingdom|Royal Marsden NHS Foundation Trust, Sutton, SM2 5PT, United Kingdom|Clatterbridge Centre for Oncology, Wirral, CH63 4JY, United Kingdom
Other Id
NV06-0039
Start Date
2006-10
Primary Completion Date
2009-04
Completion Date
2011-04
First Posted
2006-10-02
Results First Posted
Last Update Posted
2016-07-18
Study Document
Study Url
https://clinicaltrials.gov/study/NCT00382811
Title Cn
Title En
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Bilingual Status
semi_complete