Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Female

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 relapsed ovarian cancer.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Carboplatin; Farletuzumab; Taxane

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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