Safety Study of Farletuzumab, Carboplatin and Pegylated Liposomal Doxorubicin (PLD) to Treat Platinum-sensitive Ovarian Cancer

A Phase I Safety Study of Farletuzumab (MORAb-003), Carboplatin and Pegylated Liposomal Doxorubicin (PLD) in Subjects With Platinum-sensitive Ovarian Cancer

The purpose of this study is to evaluate whether combination therapy with farletuzumab (MORAb-003), carboplatin, and pegylated liposomal doxorubicin (PLD) is safe.

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

1. is safe, or
2. to assess the potential drug-drug interaction, and
3. to prolong response to chemotherapy.

Inclusion Criteria:

• Diagnosis of epithelial ovarian cancer
• Must have measurable disease by CT or MRI scan
• Must have relapsed as defined by CA-125 or radiologically within 6 months or more of completion of first- or second-line platinum chemotherapy
• Must have been treated with surgery and be a candidate for repeat carboplatin therapy
• Must have a normal cardiac ejection fraction at baseline

Exclusion Criteria:

• Subjects who never responded to first- or second-line platinum-based chemotherapy or whose relapse occurs <6 months from the last platinum therapy
• Subjects who have received other therapy to treat their ovarian cancer since last relapse
• Known central nervous system tumor involvement
• Evidence of other active invasive malignancy
• Clinically significant heart disease
• Known allergic reaction to a prior monoclonal antibody therapy or have any documented HAHA
• Previous treatment with MORAb 003 (farletuzumab)
• Previous treatment with anthracyclines
• Clinical contraindications to use PLD