Status:
COMPLETED
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-8M4 in Subjects With Advanced Ovarian Cancer
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Agensys, Inc.
Conditions:
Carcinoma
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
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.
Detailed Description
All Subjects will receive AGS-8M4 treatment. Subjects will be enrolled sequentially into 1 of the 4 planned dose cohorts according to a standard dose escalation study design. A disease assessment will...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00816764
Start Date
October 1 2008
End Date
June 1 2010
Last Update
February 27 2013
Active Locations (3)
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1
Baltimore, Maryland, United States, 19111
2
New York, New York, United States, 10021
3
New York, New York, United States, 10032