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Sponsored by: |
Morphotek |
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Information provided by: | Morphotek |
ClinicalTrials.gov Identifier: | NCT00318370 |
The purpose of this study is to determine if an investigational drug called MORAb-003 is useful by itself or when used with other approved cancer drugs in treating women with ovarian cancer. MORAb-003 is a monoclonal antibody directed against an antigen on most ovarian cancers.
Condition | Intervention | Phase |
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Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms |
Drug: MORAb-003 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse |
Estimated Enrollment: | 60 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | February 2009 |
MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) either alone or in combination with other drugs. MORAb-003 works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if MORAb-003 can work either as a single agent
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory and clinical results within the 2 weeks prior to Study Day 1 as follows:
Exclusion Criteria:
United States, California | |
Sharp HealthCare | |
San Diego, California, United States, 92123 | |
United States, Indiana | |
St. Vincent Gynecologic Oncology | |
Indianapolis, Indiana, United States, 46260 | |
United States, Louisiana | |
Jayne Gurtler, M.D. | |
Metairie, Louisiana, United States, 70006 | |
Hematology and Oncology Specialists, LLC | |
Metarie, Louisiana, United States, 70006 | |
Hematology and Oncology Specialists, LLC | |
Covington, Louisiana, United States, 70433 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21231 | |
United States, New Jersey | |
The Center for Cancer and Hematologic Disease | |
Cherry Hill, New Jersey, United States, 08003 | |
The Cancer Institute of New Jersey | |
New Brunswick, New Jersey, United States, 08901 | |
Cooper University Hospital | |
Voorhees, New Jersey, United States, 08043 | |
United States, New York | |
New York Oncology Hematology | |
Albany, New York, United States, 12206 | |
United States, Ohio | |
Gabrail Cancer Center | |
Canton, Ohio, United States, 44718 | |
United States, Pennsylvania | |
Lehigh Valley Women's Cancer Center | |
Allentown, Pennsylvania, United States, 18104 | |
United States, South Carolina | |
Gynecology Oncology Research & Development | |
Greenville, South Carolina, United States, 29601 | |
United States, Texas | |
Mary Crowley Medical Research Center | |
Dallas, Texas, United States, 75246 | |
South Texas Oncology & Hematology | |
San Antonio, Texas, United States, 78229 | |
Tyler Cancer Center | |
Tyler, Texas, United States, 75702 | |
United States, Virginia | |
Northern Virginia Pelvic Surgery Associates | |
Annandale, Virginia, United States, 22003 | |
Peninsula Cancer Center | |
Newport News, Virginia, United States, 23601 | |
Germany | |
Nationales Centrum fur Tumorerkrankungen | |
Heidelberg, Germany | |
Krankenhaus Nordwest | |
Frankfurt, Germany |
Study Director: | Martin D. Phillips, M.D. | Morphotek, Inc. |
Study ID Numbers: | MORAb-003-002 |
Study First Received: | April 24, 2006 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00318370 |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer Primary Fallopian Tube Cancer Peritoneal Cancer |
Ovarian cancer Ovarian Neoplasms Digestive System Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian epithelial cancer Abdominal Neoplasms |
Fallopian Tube Neoplasms Fallopian Tube Diseases Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Gastrointestinal Neoplasms Endocrinopathy Fallopian tube cancer Peritoneal Neoplasms Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Adnexal Diseases |