A Randomized, Double-Blind Phase II Study of Sipuleucel-T (Provenge®) Followed by Indoximod or Placebo in the Treatment of Patients With Asymptomatic or Minimally Symptomatic Metastatic Castration Resistant Prostate Cancer
Sipuleucel-T will be administered as standard of care. Oral Indoximod/placebo will be
self-administered twice daily for 6 months starting after the last infusion of sipuleucel-T.
Patients will be treated for a minimum of 12 weeks of Indoximod/placebo before disease
progression can be declared and Indoximod/placebo will not be discontinued for increasing
prostate specific antigen (PSA) in the absence of symptomatic clinical progression.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Immune Response to Sipuleucel-T
Assess the augmentation of immune response to sipuleucel-T measured at 14 weeks from first leukapheresis, in response to twice daily oral Indoximod at a dose of 1200 mg/day or an identical looking placebo.
14 Weeks from First Leukapheresis
Gautam Jha, M.D.
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
|Moffitt Cancer Center||Tampa, Florida 33612|
|Masonic Cancer Center, University of Minnesota||Minneapolis, Minnesota 55455|
|Mayo Clinic - Rochester||Rochester, Minnesota 55905|
|Georgia Health Sciences, University||Augusta, Georgia 30912|
|VA Medical Center, University of Nebraska||Omaha, Nebraska 68198|