drugset / Trial / NCT01560923

Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer

NCT01560923

Phase 2 Completed 47 enrolled Masonic Cancer Center, University of Minnesota
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a randomized, double blind, multi-institutional phase II therapeutic study of Indoximod or placebo after the completion of standard of care sipuleucel-T (Provenge®) in men with asymptomatic or minimally symptomatic metastatic prostate cancer that is castration resistant (hormone refractory). Patients are randomized to receive either twice daily oral Indoximod or placebo for 6 months beginning the day after the third and final sipuleucel-T infusion.

Timeline

Start
2012-10-01
Primary completion
2018-12-12
Completion
2018-12-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Indoximod Small molecule 1200 mg Oral
Background Sipuleucel-T Cell therapy