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

Stopped early · Phase 1

Conditions studied: Carcinoma, Ovarian Cancer, Ovarian Diseases, Ovarian Neoplasms

In brief

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.

Key facts

Study ID

NCT01016054

Run by

Astellas Pharma Inc

People needed

4

Starts

2009-10-01

Expected to finish

2010-04-01

Last updated by the study team

2013-02-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• Study site — Duarte, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.