Ovarian Cancer Clinical Trial
Efficacy and Safety of Farletuzumab (MORAb-003) in Combination With Carboplatin and Taxane in Participants With Platinum-sensitive Ovarian Cancer in First Relapse
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 relapsed ovarian cancer.
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
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
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