Trial Information
An Open Label Extension Study of the Efficacy of MORAb-003 in Subjects With Platinum-Sensitive Epithelial Ovarian Cancer in First Relapse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subjects that discontinued the MORAb-003-002 study for any reason.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
CA125
Outcome Time Frame:
Every 3 weeks
Safety Issue:
No
Principal Investigator
Susan Weil, MD
Investigator Role:
Study Director
Investigator Affiliation:
Morphotek
Authority:
United States: Food and Drug Administration
Study ID:
MORAb-003-002A
NCT ID:
NCT01018563
Start Date:
November 2009
Completion Date:
December 2013
Related Keywords:
- Epithelial Ovarian Cancer
- Extension study
- Epithelial ovarian cancer
- Ovarian Neoplasms
- Neoplasms, Glandular and Epithelial
Name | Location |
Sharp Memorial Hospital |
San Diego, California 92123 |
South Texas Oncology & Hematology |
San Antonio, Texas 78207 |