Primary Outcome Measures:
- To assess the safety of the combination of farletuzumab, carboplatin, and PLD in subjects with platinum-sensitive ovarian cancer. [ Time Frame: At all study visits. ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To assess the effect of farletuzumab in combination with carboplatin and PLD on best objective response rate, time to response, and duration of response by RECIST criteria. [ Time Frame: Every 2 months ] [ Designated as safety issue: Yes ]
Drug: Farletuzumab, Carboplatin, and PLD
All subjects will receive approximately 6 cycles with carboplatin (AUC5-6) i.v. and PLD (30 mg/m2) i.v. on Day 1 of every 4-week Combination treatment cycle. In addition, subjects will also receive weekly farletuzumab at 2.5 mg/kg administered i.v. Following completion of the Combination treatment period (carboplatin/PLD/farletuzumab therapy),maintenance treatment with single agent farletuzumab will be administered once Q3W at 7.5 mg/kg until disease progression as defined by GCIG CA-125 (i.e., CA-125 is less than or equal to 2 × (ULN) documented on 2 occasions) or modified RECIST v.1.0 using CT or MRI.
- Farletuzumab (MORAb-003)
Farletuzumab (MORAb-003) is a monoclonal antibody that has the potential to be an effective agent against epithelial ovarian cancer (including primary fallopian tube and peritoneal adenocarcinoma) in combination with other drugs. Farletuzumab works by a different mechanism from other cancer therapeutics and has been shown to be well tolerated. This study allows the opportunity to determine if the combination therapy of farletuzumab, carboplatin, and PLD
- is safe, or
- to assess the potential drug-drug interaction, and
- to prolong response to chemotherapy.