drugset / Trial / NCT01560923
Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Indoximod | Small molecule | 1200 mg | Oral |
| Background | Sipuleucel-T | Cell therapy | — | — |