A Study of the Safety and Pharmacokinetics of AGS-8M4 Given in Combination With Chemotherapy in Women With Ovarian Cancer

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

Summary

This is a parallel arm study to evaluate AGS-8M4 administered in combination with chemotherapy in subjects with ovarian cancer. AGS-8M4 will be administered as an IV infusion until disease worsens.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Agensys, Inc.
• Treatments: Carboplatin; Doxorubicin; Gemcitabine; Liposomal doxorubicin

Criteria

Inclusion Criteria:

• Subjects with recurrent disease Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma

• Subjects with either platinum resistant or platinum sensitive ovarian cancer

• At least 14 days of previous cytotoxic chemotherapy and have recovered from all toxicities

• Left ventricular ejection fraction (LVEF) equal to or greater than the institutional lower limit of normal as measured by echocardiogram or MUGA (ONLY required for platinum resistant patients)

Exclusion Criteria:

• Active infection requiring treatment with systemic (intravenous or oral) anti-infectives (antibiotic, antifungal, or antiviral agent) within 72 hours of screening

• Use of any investigational drug within 30 days prior to screening

• Prior monoclonal antibody therapy other than Avastin

• Avastin administration within 90 days of screening

• History of thromboembolic events and bleeding disorders ≤ 3 months (e.g.,DVT or PE)