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NCT01487863 · ClinicalTrials.gov registry record · Phase 2
Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer
A Phase 2 study, sponsored by Dendreon.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT01487863: Completed Phase 2 study, sponsored by Dendreon.
NCT01487863 is a Phase 2 study that has completed, run by Dendreon. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01487863, a Phase 2 study, has completed, sponsored by Dendreon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent or sequential administration of abiraterone acetate plus prednisone in men with metastatic castrate resistant prostate cancer.
Primary Outcome
An analysis of variance model for the log transformed cumulative CD54 upregulation ratio (CD54 upregulation is the fold increase in the final product (FP) from buoyant density separations (BDS) step 65. BDS65 step refers to sample taken after both BDS77 and BDS65 but before ex vivo culture in the presence of antigen PA2024. FP refers to sample taken after ex vivo culture) that includes the antigen concentration cohort as the independent variable was performed. Subjects who received all 3 infusio
Interventions
- DRUG abiraterone acetate
- BIOLOGICAL sipuleucel-T
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT01487863 record still lists
NCT01487863 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which abiraterone acetate is the first listed.
NCT01487863 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01487863 about?
NCT01487863 is a clinical study titled "Concurrent vs. Sequential Sipuleucel-T & Abiraterone Treatment in Men With Metastatic Castrate Resistant Prostate Cancer". The purpose of this study was to evaluate the impact of concurrent versus sequential administration of abiraterone acetate plus prednisone on the ability to manufacture sipuleucel-T (by assessing sipuleucel-T product parameters), and to assess the safety and efficacy of sipuleucel-T with concurrent ...
What is the current status of trial NCT01487863?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2011-12. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01487863?
The interventions under investigation include: abiraterone acetate (DRUG), sipuleucel-T (BIOLOGICAL).
Who is sponsoring clinical trial NCT01487863?
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 NCT01487863's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 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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