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A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab)in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer

Phase 3
18 Years
Not Enrolling
Ovarian Cancer

Thank you

Trial Information

A Randomized, Double Blind, Placebo-Controlled Study of the Efficacy and Safety oF MORAb-003(Farletuzumab)in Combination With Paclitaxel Therapy in Subjects With Platinum-Resistant or Refractory Relapsed Ovarian Cancer

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

- 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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression-free survival (PFS) as determined by RECIST

Outcome Description:

PFS as determined by RECIST

Outcome Time Frame:

Length of Study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

September 2008

Completion Date:

April 2012

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • relapsed ovarian cancer
  • refractory ovarian cancer
  • Ovarian Neoplasms



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