Trials / Completed
CompletedNCT01560923
Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 47 (actual)
- Sponsor
- Masonic Cancer Center, University of Minnesota · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Indoximod | Given twice daily (1200 mg total) by mouth for 6 months. |
| BIOLOGICAL | Sipuleucel-T | Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday). |
| OTHER | Placebo | Given in same manner as Indoximod; 1200 mg per day by mouth. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2018-12-12
- Completion
- 2018-12-12
- First posted
- 2012-03-22
- Last updated
- 2020-04-03
- Results posted
- 2020-04-03
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01560923. Inclusion in this directory is not an endorsement.