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NCT03093272 · ClinicalTrials.gov registry record · Phase 2
A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT03093272: Clinical Trial Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT03093272 is a Phase 2 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 9 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03093272, a Phase 2 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This research study is studying a combination of drugs as a possible treatment for castration-resistant prostate cancer. The interventions involved in this study are: * Docetaxel (a type of chemotherapy) * Apalutamide (the study medication, also known as ARN-509) * Prednisone (a corticosteroid given to prevent reactions to docetaxel). * Leuprolide acetate (also known as Lupron, a GnRH agonist or similar drug which is standard of care, causes chemical castration which greatly lowers the level of testosterone in the body)
Primary Outcome
Progression free survival (PFS) is defined as the time from treatment initiation until the occurrence of one of the following: 1. A participant was considered to have progressed by bone scan if 1. the first bone scan with greater than or equal to (≥) 2 new lesions compared to baseline was observed in less than (\<) 12 weeks from study drug initiation and was confirmed by a second bone scan taken ≥6 weeks later showing ≥2 additional new lesions (a total of ≥4 new lesions compared to baseline
Interventions
- DRUG Docetaxel
- DRUG Apalutamide
- DRUG Prednisone
- DRUG Leuprolide Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-06-23 |
| Est. Completion | 2019-12-31 |
| Phase | Phase 2 |
Why NCT03093272 stopped before completion
NCT03093272 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 4 interventions - of which Docetaxel is the first listed.
NCT03093272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03093272 about?
NCT03093272 is a clinical study titled "A Study of Docetaxel + ARN-509 in Castration-Resistant Prostate Cancer". This research study is studying a combination of drugs as a possible treatment for castration-resistant prostate cancer. The interventions involved in this study are: * Docetaxel (a type of chemotherapy) * Apalutamide (the study medication, also known as ARN-509) * Prednisone (a corticosteroid giv...
What is the current status of trial NCT03093272?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2017-06-23. Estimated completion is 2019-12-31.
What interventions are being tested in trial NCT03093272?
The interventions under investigation include: Docetaxel (DRUG), Apalutamide (DRUG), Prednisone (DRUG), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT03093272?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03093272's enrollment target sits among peer trials
9 1989th of 2000 higher than 11 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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