Study of Efficacy and Safety of MORAb-003 in Patients (Subjects) With Platinum-Sensitive Ovarian Cancer in First Relapse.
- Conditions
- Health Condition 1: null- Platinum sensitive Ovarian Cancer
- Registration Number
- CTRI/2009/091/000345
- Lead Sponsor
- Morphotek Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 900
1. A histologically or cytologically confirmed diagnosis of non-mucinous epithelial ovarian cancer including primary peritoneal or fallopian tube malignancies
2. Must have measurable disease by CT or MRI scan
3. Must have relapsed radiologically within ≥6 and < 24 months of completion of first-line platinum/taxane chemotherapy
4. Must be a candidate for repeat carboplatin/taxane therapy
5. Neurologic function: neuropathy (sensory and motor) ≤CTCAE Grade 1
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
2.Subjects who have received other therapy to treat their ovarian cancer since relapse
3.Known central nervous system (CNS) tumor involvement
4.Evidence of other active invasive malignancy requiring treatment in the past 5 years
5.Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
6.Previous treatment with MORAb-003 (farletuzumab)
7.Clinical contraindications to use of a taxane
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression-free survival using by RECISTTimepoint: Time Frame: 3 years
- Secondary Outcome Measures
Name Time Method Overall Survival, CA-125 PFS, GCIG PFS, Length of first versus second remission, Tumor Response,Serologic Response (CA-125), Quality of Life, Resource utilization and PK DDI substudyTimepoint: Time Frame: 4 years