A Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
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
1. to treat a CA125-only relapse, or
2. in combination with standard platinum and taxane chemotherapy to treat a symptomatic
relapse, and
3. to prolong a second response to chemotherapy.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Serologic Response (Change in CA125 Level)
Defined using modified Gynecologic Cancer Intergroup (GCIG) criteria: Number of participants who achieved a 50% response = >50% decrease from baseline CA-125 (higher of 2 pretreatment CA-125 assessments and the level must be at least 52.5 kU/L).
Baseline to response (up to 30 weeks)
No
Susan C. Weil, M.D.
Study Director
Morphotek, Inc.
United States: Food and Drug Administration
MORAb-003-002
NCT00318370
May 2006
June 2010
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Cooper University Hospital | Camden, New Jersey 08103 |
Mary Crowley Medical Research Center | Dallas, Texas 75246 |
Tyler Cancer Center | Tyler, Texas 75702 |
The Center for Cancer and Hematologic Disease | Cherry Hill, New Jersey 08003 |
Sharp Healthcare | San Diego, California 92121 |
Gabrail Cancer Center | Canton, Ohio 44718 |
Hematology and Oncology Specialists, LLC | New Orleans, Louisiana 70115 |
St. Vincent Gynecologic Oncology | Indianapolis, Indiana 46260 |
The Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
New York Oncology Hematology | Albany, New York 12208 |
South Texas Oncology & Hematology | San Antonio, Texas 78207 |
Northern Virginia Pelvic Surgery Associates | Annandale, Virginia 22003 |
Jayne Gurtler, M.D. | Metairie, Louisiana 70006 |
Lehigh Valley Women's Cancer Center | Allentown, Pennsylvania 18104 |
Gynecology Oncology Research & Development | Greenville, South Carolina 29601 |
Peninsula Cancer Center | Newport News, Virginia 23601 |