Conditions: Ovarian Cancer
Keywords: ovarian cancer relapsed ovarian cancer refractory ovarian cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 415
Healthy volunteers: no

Brief 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

Detailed description:
Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.

Arms:
arm 1: MORAb-003 (Farletuzumab) Plus Paclitaxel arm 2: Placebo Plus Paclitaxel

Interventions: intervention 1: MORAb-003 (farletuzumab) intervention 2: 0.9% Saline intervention 3: Paclitaxel
Intervention descriptions: intervention 1: 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. intervention 2: 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 3: None

Protocol document: