A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
18 Years
N/A
Both
Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases
Trial Information
A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
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 investigator. The assessment will be based both on changes in clinical
symptoms, and radiographic images. Subjects without evidence of disease progression may
receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until
disease progression or intolerability of AGS-16M18. Disease assessments will be performed
every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after
the last infusion of AGS-16M18.
Inclusion Criteria:
- 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 Criteria:
- 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 PE)
- Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of adverse events
Outcome Time Frame:
Throughout the treatment
Safety Issue:
No
Principal Investigator
Use Central Contact
Investigator Role:
Study Director
Investigator Affiliation:
Agensys, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
2007002
NCT ID:
NCT00816686
Start Date:
October 2008
Completion Date:
April 2010
Related Keywords:
- Carcinoma, Renal Cell
- Kidney Neoplasms
- Kidney Diseases
- clinical trial, phase 1
- carcinoma, advanced renal cell
- kidney
- pharmacokinetics
- safety
- AGS-16M18
- Neoplasms
- Carcinoma
- Carcinoma, Renal Cell
- Kidney Diseases
- Kidney Neoplasms
Name | Location |
|---|---|
| Albany, New York 12208 | |
| Baltimore, Maryland 21287 |
