Status:
TERMINATED
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
Lead Sponsor:
Morphotek
Collaborating Sponsors:
Eisai Europe Ltd. (United Kingdom)
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This research is being done to find out if Carboplatin and Taxane works better alone or when given with an experimental drug called MORAb-003(farletuzumab) in subjects with first platinum sensitive re...
Eligibility Criteria
Inclusion
- A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
- Must have measurable disease by CT or MRI scan
- Must have relapsed radiologically with a randomization date within ≥6 and \< 24 months of completion of first-line platinum chemotherapy
- Have been treated with debulking surgery and first-line platinum and taxane based chemotherapy.
- Prior bevacizumbab maintenance is allowed. The last dose of bevacizumab must have been at least 30 days before study Day 1. No cytotoxic maintenance therapy (e.g. taxane) or cancer vaccine therapy is allowed.
- Must be a candidate for carboplatin and taxane therapy
- Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1
Exclusion
- Subjects who never responded to first-line platinum-based therapy or whose first relapse occurs \<6 months or \>24 months from the last platinum therapy
- Subjects who have received other therapy to treat their ovarian cancer since relapse
- Known central nervous system (CNS) tumor involvement
- Evidence of other active invasive malignancy requiring treatment in the past 5 years
- Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
- Previous treatment with MORAb-003 (farletuzumab)
- Clinical contraindications to use of a taxane
Key Trial Info
Start Date :
April 16 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2013
Estimated Enrollment :
1100 Patients enrolled
Trial Details
Trial ID
NCT00849667
Start Date
April 16 2009
End Date
April 12 2013
Last Update
December 30 2022
Active Locations (375)
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1
University Of Alabama At Birmingham
Birmingham, Alabama, United States, 35233
2
Oncology Specialties, PC
Huntsville, Alabama, United States, 35801
3
Arizona Hematology & Oncology Associates
Phoenix, Arizona, United States, 85012
4
St. Joseph's Hospital, Barrow Neurology Clinics
Phoenix, Arizona, United States, 85013