A Phase II Study of Talabostat in Patients With Metastatic Renal Cell Carcinoma
- Determine the response rate in patients with metastatic renal cell carcinoma treated
with talabostat mesylate.
- Determine the progression-free survival of patients treated with this drug.
- Determine the toxicity of this drug in these patients.
- Correlate changes in specific cytokine levels and peripheral blood flow cytometry with
OUTLINE: This is a nonrandomized study.
Patients receive oral talabostat mesylate once daily on days 1-14. Courses repeat every 21
days in the absence of disease progression or unacceptable toxicity.
Blood samples are obtained from patients at baseline and after each course for biomarker
correlative studies. Samples are analyzed for serum cytokines and chemokines and for T-cell
subsets and NK cells by flow cytometry. Peripheral blood lymphocytes are obtained at
baseline and after course 1 for future assessment by gene microarray analysis.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
At progression or death from any cause
Ralph Hauke, MD
University of Nebraska
United States: Food and Drug Administration