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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 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 47 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01560923
The ClinicalTrials.gov registry entry for NCT01560923 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 47 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01560923 reports 0 study locations.
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.
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