Overview

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