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

• Status: Completed
• Trial end date: 2012-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Morphotek
• Treatments: Carboplatin; Doxorubicin; Farletuzumab; Liposomal doxorubicin

Criteria

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