Spots Global Cancer Trial Database for An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
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Trial Identification
Brief Title: An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Official Title: A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab) in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Study ID: NCT00738699
Conditions
Study Description
Brief Summary: The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer
Detailed Description: Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Southern Cancer Center, Mobile, Alabama, United States
St. Joseph's Hospital and Medical Center, Phoenix, Arizona, United States
California Cancer Care, Inc., Greenbrae, California, United States
Moores UC San Diego Cancer Center, La Jolla, California, United States
USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Monterey Bay Oncology, Monterey, California, United States
Jupiter Medical Center, Jupiter, Florida, United States
Innovative Medical Research of South Florida, Inc., Miami, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Sarasota Memorial Hospital, Sarasota, Florida, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Central DuPage Hospital, Winfield, Illinois, United States
St. Vincent Gynecologic Oncology, Indianapolis, Indiana, United States
Hematology and Oncology Specialists, LLC, Metairie, Louisiana, United States
Johns Hopkins Hospital, Baltimore, Maryland, United States
Weinberg Cancer Institute at Franklin Square, Baltimore, Maryland, United States
Henry Ford Health System, Detroit, Michigan, United States
Morristown Memorial Hospital, Morristown, New Jersey, United States
Schwartz Gynecologic Oncology, PLLC, Brightwaters, New York, United States
Arena Oncology Associates, PC, Lake Success, New York, United States
St. Luke's Roosevelt Hospital Center, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Piedmont Hematology Oncology Associates, PA, Winston Salem, North Carolina, United States
Cleveland Clinic, Cleveland, Ohio, United States
Signal Point Clinical Research Center, Middletown, Ohio, United States
Cancer Care Associates, Tulsa, Oklahoma, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Magee-Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Medical University of South Carolina, Charleston, South Carolina, United States
International Beneficence Clinical Research, LLC, Harlingen, Texas, United States
South Texas Oncology & Hematology PA, San Antonio, Texas, United States
Scott & White Memorial Hospital and Clinic, Temple, Texas, United States
Utah Cancer Specialists, Salt Lake City, Utah, United States
Northern Virginia Pelvic Surgery Associates, Annandale, Virginia, United States
Prince of Wales Hospital, Randwick, New South Wales, Australia
Westmead Hospital, Westmead, New South Wales, Australia
Royal Brisbane & Women's Hospital, Herston, Queensland, Australia
The Burnside War Memorial Hospital, Inc., Toorak Gardens, South Australia, Australia
Monash Medical Centre, East Bentleigh, Victoria, Australia
Mercy Hospital for Women, Heidelburg, Victoria, Australia
The Royal Women's Hospital, Parkville, Victoria, Australia
Sir Charles Gairdner Hospital, Nedlands, Western Australia, Australia
St. John of God Hospital, Subiaco, Western Australia, Australia
AZ Greninge Hospital, Kortrijk, , Belgium
University Hospitals Leuven, Leuven, , Belgium
CHU de Liege, Liege, , Belgium
Tom Baker Cancer Centre, Calgary, Alberta, Canada
BC Cancer Agency, Kelowna, British Columbia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
UMCG, Groningen, , Netherlands
University Hospital Maastricht, Maastricht, , Netherlands
UMC Utrecht, Utrecht, , Netherlands
Hospital Universitario Son Dureta, Palma de Mallorca, Baleares, Spain
Hospital de Son Llatzer, Palma de Mallorca, Baleares, Spain
Hospital de Mataro, Mataro, Barcelona, Spain
Corporacio Sanitaria Parc Taulis, Sabadell, Barcelona, Spain
Consorci Sanitari de Terrassa, Terrassa, Barcelona, Spain
Fundacion Hospital Alcorcon, Alcorcon, Madrid, Spain
Hospital Clinic I Provincial, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Contact Details
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