Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse
- Conditions
- Ovarian Cancer
- Registration Number
- JPRN-jRCT2080221321
- Lead Sponsor
- Eisai Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- 900
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 >- 6 and -< 24 months of completion of first-line platinum/taxane chemotherapy
Must be a candidate for repeat carboplatin/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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method