An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer

• Status: Terminated
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: Female

Summary

The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Albumin-Bound Paclitaxel; Farletuzumab; Paclitaxel

Criteria

Inclusion Criteria:

• Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry

• Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.

• Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;

• Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.

• Subjects must be candidate for repeat paclitaxel treatment

Exclusion Criteria:

• Clinical contraindications to use of paclitaxel, which include:

1. persistent Grade 2 or greater peripheral neuropathy

2. prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation

• Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did

• Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal

• Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).

• Previous treatment with MORAb-003 (farletuzumab).