A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer

Stopped early · Phase 1

Conditions studied: Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases

In brief

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 disease worsens.

Key facts

Study ID

NCT00816686

Run by

Astellas Pharma Inc

People needed

7

Starts

2008-10-01

Expected to finish

2010-04-01

Last updated by the study team

2013-02-27

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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