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NCT01981122 · ClinicalTrials.gov registry record · Phase 2
A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer
A Phase 2 study, sponsored by Dendreon.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT01981122: Completed Phase 2 study, sponsored by Dendreon.
NCT01981122 is a Phase 2 study that has completed, run by Dendreon. The registered enrollment target is 52 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01981122, a Phase 2 study, has completed, sponsored by Dendreon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.
Primary Outcome
PA2024-specific T cell proliferation responses over time will be compared between the concurrent arm and sequential arm using a repeated measurement mixed model analysis. The unit of analysis for the T cell proliferation data is the stimulation index, defined as the median 3H uptake of 3 wells exposed to antigen divided by the median 3H thymidine uptake of 3 wells exposed to media. The stimulation index will be log-transformed prior to analysis.
Interventions
- DRUG enzalutamide
- BIOLOGICAL sipuleucel-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2013-09 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 2 |
What the finished NCT01981122 record still lists
NCT01981122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (61% lower).
The record links to 0 conditions, and to 2 interventions - of which enzalutamide is the first listed.
NCT01981122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01981122 about?
NCT01981122 is a clinical study titled "A Study of Sipuleucel-T With Administration of Enzalutamide in Men With Metastatic Castrate-Resistant Prostate Cancer". This is a randomized, open-label study designed to assess the effects of sipuleucel-T when administered concurrently or sequentially with enzalutamide.
What is the current status of trial NCT01981122?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2013-09. Estimated completion is 2017-06-30.
What interventions are being tested in trial NCT01981122?
The interventions under investigation include: enzalutamide (DRUG), sipuleucel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT01981122?
This trial is sponsored by Dendreon, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01981122's enrollment target sits among peer trials
52 1181st of 2000 higher than 811 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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