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NCT01560923 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
NCT01560923: Completed Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT01560923 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 47 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560923, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
Assess the augmentation of immune response (PA2024) 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. The frequency of antigen specific, cytokine producing cells will be determined by an ELISPOT assay. ELISPOT assay will use whole PBMC to assess interferon gamma production in response to the immunizing protein PA2024. Increase in number of ELISPOT responses to PBMC in patients in the
Interventions
- OTHER Placebo
- BIOLOGICAL Sipuleucel-T
- BIOLOGICAL Indoximod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2012-10-01 |
| Est. Completion | 2018-12-12 |
| Phase | Phase 2 |
What the finished NCT01560923 record still lists
NCT01560923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01560923 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560923 about?
NCT01560923 is a clinical study titled "Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer". 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)....
What is the current status of trial NCT01560923?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2012-10-01. Estimated completion is 2018-12-12.
What interventions are being tested in trial NCT01560923?
The interventions under investigation include: Placebo (OTHER), Sipuleucel-T (BIOLOGICAL), Indoximod (BIOLOGICAL).
Who is sponsoring clinical trial NCT01560923?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01560923's enrollment target sits among peer trials
47 1283rd of 2000 higher than 715 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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