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NCT01597908 · ClinicalTrials.gov registry record · Phase 3
Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 704
- Enrollment target
NCT01597908: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01597908 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 704 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01597908, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 704 participants
- Enrollment target
Study Summary
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
Primary Outcome
Overall Survival (OS) was defined as the interval of time between the date of randomization and the date of death due to any cause. For patients who did not die, OS was censored at the date of last contact.
Interventions
- DRUG Trametinib
- DRUG Vemurafenib
- DRUG Dabrafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 704 participants |
| Start Date | 2012-06-04 |
| Est. Completion | 2019-04-25 |
| Phase | Phase 3 |
What the finished NCT01597908 record still lists
NCT01597908 is an interventional study that assigns participants to a tested intervention. The registered 704 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 3 interventions - of which Trametinib is the first listed.
NCT01597908 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01597908 about?
NCT01597908 is a clinical study titled "Dabrafenib Plus Trametinib vs Vemurafenib Alone in Unresectable or Metastatic BRAF V600E/K Cutaneous Melanoma". This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
What is the current status of trial NCT01597908?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 704 participants. The study started on 2012-06-04. Estimated completion is 2019-04-25.
What interventions are being tested in trial NCT01597908?
The interventions under investigation include: Trametinib (DRUG), Vemurafenib (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT01597908?
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 NCT01597908's enrollment target sits among peer trials
704 506th of 2000 higher than 1,495 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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