An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
- Provision of Informed consent
- Subjects must have been enrolled in and have met the inclusion/exclusion criteria of
the MORAb-003-002 study.
- Subjects must have achieved a normalization of CA 125 levels and/or CR or PR (or
stable disease and an investigator's assessment of a clinical benefit) after
MORAb-003 in combination with standard chemotherapy and have not yet met the criteria
for disease progression during participation in the MORAb-003-002 study.
- Subjects must be currently receiving single-agent MORAb-003 maintenance therapy.
- Subjects that discontinued the MORAb-003-002 study for any reason.
Type of Study:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Time Frame:
Every 3 weeks
Susan Weil, MD
United States: Food and Drug Administration
- Epithelial Ovarian Cancer
- Extension study
- Epithelial ovarian cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
|Sharp Memorial Hospital||San Diego, California 92123|
|South Texas Oncology & Hematology||San Antonio, Texas 78207|