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NCT01512251 · ClinicalTrials.gov registry record · Phase 1
BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma
A Phase 1 study, sponsored by University of California, San Francisco.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT01512251: Completed Phase 1 study, sponsored by University of California, San Francisco.
NCT01512251 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01512251, a Phase 1 study, has completed, sponsored by University of California, San Francisco.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
This is a phase 1/2 clinical trial with the goal of determining whether the addition of the investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free survival in patients with BRAFV600E/K mutant melanoma.
Primary Outcome
RP2D determined by maximum tolerated dose (MTD), post-dose-limiting toxicity (DLT) period toxicity, and pharmacokinetic data
Interventions
- DRUG BKM120 Combined with Vemurafenib (PLX4032)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2012-06-09 |
| Est. Completion | 2017-03-21 |
| Phase | Phase 1 |
What the finished NCT01512251 record still lists
NCT01512251 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 1 intervention - of which BKM120 Combined with Vemurafenib (PLX4032) is the first listed.
NCT01512251 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01512251 about?
NCT01512251 is a clinical study titled "BKM120 Combined With Vemurafenib (PLX4032) in BRAFV600E/K Mutant Advanced Melanoma". This is a phase 1/2 clinical trial with the goal of determining whether the addition of the investigational agent BKM120 to vemurafenib will lead to improved 6-month progression-free survival in patients with BRAFV600E/K mutant melanoma.
What is the current status of trial NCT01512251?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2012-06-09. Estimated completion is 2017-03-21.
What interventions are being tested in trial NCT01512251?
The interventions under investigation include: BKM120 Combined with Vemurafenib (PLX4032) (DRUG).
Who is sponsoring clinical trial NCT01512251?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01512251's enrollment target sits among peer trials
8 1959th of 2000 higher than 29 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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