Status:
TERMINATED
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer
Lead Sponsor:
Astellas Pharma Inc
Collaborating Sponsors:
Agensys, Inc.
Conditions:
Carcinoma, Renal Cell
Kidney Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the diseas...
Detailed Description
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the inv...
Eligibility Criteria
Inclusion
- Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
- Evaluable/Measureable disease according to Response Criteria for Solid tumors
- Eastern Cooperative Group performance status of 0-1
- Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and \>/= 3 months from initiation
Exclusion
- Past or present documented central nervous system (CNS) tumor or CNS metastasis
- Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
- History of thromboembolic events and bleeding disorders \</= 3 months (e.g., DVT or PE)
- Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00816686
Start Date
October 1 2008
End Date
April 1 2010
Last Update
February 27 2013
Active Locations (2)
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1
Baltimore, Maryland, United States, 21231
2
New York, New York, United States, 10021