An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: MORAb-003 (farletuzumab); 0.9% Saline; Paclitaxel
Intervention description: Farletuzumab (FAR) at 2.5 mg/kg was administered by intravenous (IV) infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.; Placebo (0.9% normal saline) was administered by IV infusion weekly on Day 1 of Weeks 1 to 12 (Cycle 1) and then in 4-week cycles with treatment administered on Day 1 of Weeks 1 to 3 for all subsequent cycles.
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Farletuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 415.0
Sex: Female
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: ovarian cancer; relapsed ovarian cancer; refractory ovarian cancer

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
    

Eligibility 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).