Overview

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).