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NCT01634061 · ClinicalTrials.gov registry record · Phase 1
Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT01634061: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01634061 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 43 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01634061, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.
Primary Outcome
Dose escalation part: Determine MTD and /or RDE of the combinations abiraterone acetate + BEZ235 and abiraterone acetate + BKM120 by assessing the incidence of DLTs in cycle 1
Interventions
- DRUG BEZ235
- DRUG BKM120
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2012-09 |
| Est. Completion | 2015-07 |
| Phase | Phase 1 |
What the finished NCT01634061 record still lists
NCT01634061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which BEZ235 is the first listed.
NCT01634061 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01634061 about?
NCT01634061 is a clinical study titled "Phase Ib of Abiraterone Acetate Plus BEZ235 or BKM120 in Castration-resistant Prostate Cancer (CRPC) Patients". This is an open label study of abiraterone acetate in combination with BEZ235 and abiraterone acetate in combination with BKM120 in CRPC patients with abiraterone acetate failure.
What is the current status of trial NCT01634061?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2012-09. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01634061?
The interventions under investigation include: BEZ235 (DRUG), BKM120 (DRUG).
Who is sponsoring clinical trial NCT01634061?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01634061's enrollment target sits among peer trials
43 1100th of 2000 higher than 896 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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