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A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

Phase 3
18 Years
Open (Enrolling)
Ovarian Cancer

Thank you

Trial Information

A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Weekly MORAb-003 in Combination With Carboplatin and Taxane in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse

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

- 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

- Previous treatment with MORAb-003 (farletuzumab)

- Clinical contraindications to use of a taxane

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 using by RECIST

Outcome Time Frame:

3 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

July 2013

Related Keywords:

  • Ovarian Cancer
  • ovarian cancer
  • relapsed ovarian cancer
  • Platinum-sensitive Ovarian Cancer
  • Ovarian Neoplasms



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