A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer

Completed · Phase 1

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

In brief

This is the first in human study of AGS-8M4 given every 2 weeks to subjects with advanced ovarian cancer. AGS-8M4 will be administered as an IV infusion until the disease worsens.

Key facts

Study ID

NCT00816764

Run by

Astellas Pharma Inc

People needed

18

Starts

2008-10-01

Expected to finish

2010-06-01

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 or histologically or cytologically confirmed Stage III/IV diagnosis of epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma
• Subjects must have received at least one prior platinum containing regimen and one of the following: persistent disease (either stable disease, partial response or nonmeasureable disease after first line therapy) or progressive disease at anytime

You may not qualify if…

• No epithelial ovarian tumors of low malignant potential
• Active infection requiring treatment with systemic anti-infectives within 72 hours of screening
• Use of any investigational drug within 30 days prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
• Prior monoclonal antibody therapy

Where it is running

• Study site — Baltimore, Maryland, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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