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NCT01741753 · ClinicalTrials.gov registry record · Phase 1
BKM120+Abiraterone Acetate for Metastatic CRPC
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Terminated
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
NCT01741753: Clinical Trial Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT01741753 is a Phase 1 study that was terminated before completion, run by Dana-Farber Cancer Institute. The registered enrollment target is 4 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01741753, a Phase 1 study, was terminated before completion, sponsored by Dana-Farber Cancer Institute.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
Study Summary
This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and taht research doctors are trying to find out more about it. It also means that the FDA has not approved the drug for use in patients, including people with your type of cancer. BKM120 is a drug that inhibits the ability of tumors to grow and survive, which may lead to better outcomes in many types of cancer. Abiraterone acetate is a drug that is approved for the treatment of prostate cancer, and works by inhibiting an enzyme found in prostate tumor tissue. While taking abiraterone acetate, individuals must also take a glucocorticoid such as prednisone. Most patients with castrate-resistant prostate cancer will receive treatment with docetaxel, after which treatment with the combination of abiraterone and prednisone has been shown to be effective. Evidence has shown an interaction between the pathways through which BKM120 and abiraterone act on cancer. Therefore, it is thought that the treatment of castrate-resistant prostate cancer will be enhanced by combining BKM120 with abiraterone plus prednisone. The purpose of this study is to determine a safe dose for the combination of daily oral BKM120, abiraterone acetate, and prednisone in patients with castrate-resistant metastatic prostate cancer who have received prior treatment with docetaxel.
Primary Outcome
Determine the safety profile and MTD for the combination of BKM120 and abiraterone plus prednisone
Interventions
- DRUG Prednisone
- DRUG Abiraterone
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2012-11 |
| Est. Completion | 2016-09-01 |
| Phase | Phase 1 |
Why NCT01741753 stopped before completion
NCT01741753 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 3 interventions - of which Prednisone is the first listed.
NCT01741753 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01741753 about?
NCT01741753 is a clinical study titled "BKM120+Abiraterone Acetate for Metastatic CRPC". This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug, in this case an investigational drug combined with standard drug therapy. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studie...
What is the current status of trial NCT01741753?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2012-11. Estimated completion is 2016-09-01.
What interventions are being tested in trial NCT01741753?
The interventions under investigation include: Prednisone (DRUG), Abiraterone (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01741753?
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 NCT01741753's enrollment target sits among peer trials
4 1995th of 2000 higher than 2 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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