AE-941 (NEOVASTAT) Versus Placebo in Metastatic Renal Cell Carcinoma Patients Who Are Refractory to Immunotherapy
OBJECTIVES: I. Compare survival of patients with metastatic renal cell carcinoma refractory
to immunotherapy treated with AE-941 (Neovastat) versus placebo. II. Compare the time to
progression and one-year survival rate of patients treated with this regimen. III. Determine
the safety of this regimen in these patients. IV. Compare the overall tumor response rate,
duration of response, and quality of life of patients treated with this regimen.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
are stratified according to number of organs with metastases (1 vs more than 1) and ECOG
performance status (0 vs 1). Patients are randomized to one of two treatment arms. Arm I:
Patients receive oral AE-941 (Neovastat) twice a day. Arm II: Patients receive oral placebo
twice a day. Treatment continues in the absence of unacceptable toxicity or disease
progression. Quality of life is assessed on day 1 and then every 8 weeks thereafter.
Patients are followed every 4 weeks until disease progression and then every 8 weeks
PROJECTED ACCRUAL: A total of 280 patients will be accrued for this study within 12 months.
Primary Purpose: Treatment
United States: Federal Government