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NCT01254864 · ClinicalTrials.gov registry record · Phase 2
Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 190
- Enrollment target
NCT01254864: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT01254864 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 190 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01254864, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 190 participants
- Enrollment target
Study Summary
You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body. This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being researched. Sunitinib malate is FDA-approved for the treatment of gastrointestinal tumors and renal cell carcinoma, and dasatinib is FDA approved and commercially available for certain types of leukemia. The use of these drugs in prostate cancer and in combination with abiraterone acetate and prednisone is investigational. Up to 180 patients will be enrolled in this study. All will be enrolled at MD Anderson.
Primary Outcome
Time to treatment failure (TTF), defined as time from randomization (AP+S or AP+D) to progression per PCWG2 criteria or death.
Interventions
- DRUG Sunitinib
- DRUG Prednisone
- DRUG Dasatinib
- DRUG Abiraterone Acetate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 190 participants |
| Start Date | 2011-03-16 |
| Est. Completion | 2023-12-07 |
| Phase | Phase 2 |
What the finished NCT01254864 record still lists
NCT01254864 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% higher).
The record links to 0 conditions, and to 4 interventions - of which Sunitinib is the first listed.
NCT01254864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01254864 about?
NCT01254864 is a clinical study titled "Maximal Androgen Depletion Followed by Randomization of Maximal Androgen Ablation With Molecular Targeted Therapies". You are being asked to take part in this study because you have prostate cancer that has spread to other parts of the body. This is an investigational study. Prednisone is FDA-approved and commercially available. Abiraterone acetate is FDA-approved and commercially available, but is still being res...
What is the current status of trial NCT01254864?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 190 participants. The study started on 2011-03-16. Estimated completion is 2023-12-07.
What interventions are being tested in trial NCT01254864?
The interventions under investigation include: Sunitinib (DRUG), Prednisone (DRUG), Dasatinib (DRUG), Abiraterone Acetate (DRUG).
Who is sponsoring clinical trial NCT01254864?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01254864's enrollment target sits among peer trials
190 353rd of 2000 higher than 1,646 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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