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NCT01721603 · ClinicalTrials.gov registry record · Phase 2
Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets
A Phase 2 study, sponsored by University of California, San Francisco.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01721603: Clinical Trial Phase 2 study, sponsored by University of California, San Francisco.
NCT01721603 is a Phase 2 study that was terminated before completion, run by University of California, San Francisco. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01721603, a Phase 2 study, was terminated before completion, sponsored by University of California, San Francisco.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
The purpose of this study is to test the safety and find out what effects, good and/or bad, dabrafenib (a BRAF inhibitor) alone or dabrafenib when given in combination with gamma knife radiosurgery has on participants with a certain type of skin cancer (BRAFV600E melanoma) and brain metastases (tumors that have spread to the brain).
Primary Outcome
Determine whether dabrafenib combined with stereotactic radiosurgery (SRS) and trametinib improves the 6 month DBMFS rate of BRAFV600E melanoma patients for whom the standard of care is stereotactic radiosurgery (≤4 brain lesions and no lesion \> 3 cm) in comparison with similar historical controls treated with radiosurgery alone.
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
- PROCEDURE Gamma Knife Radiosurgery
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-04 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
Why NCT01721603 stopped before completion
NCT01721603 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which Trametinib is the first listed.
NCT01721603 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01721603 about?
NCT01721603 is a clinical study titled "Dabrafenib and Trametinib With Radiosurgery in Melanoma Brain Mets". The purpose of this study is to test the safety and find out what effects, good and/or bad, dabrafenib (a BRAF inhibitor) alone or dabrafenib when given in combination with gamma knife radiosurgery has on participants with a certain type of skin cancer (BRAFV600E melanoma) and brain metastases (tumo...
What is the current status of trial NCT01721603?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-04. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01721603?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG), Gamma Knife Radiosurgery (PROCEDURE).
Who is sponsoring clinical trial NCT01721603?
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 NCT01721603's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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