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NCT01584648 · ClinicalTrials.gov registry record · Phase 3
A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 423
- Enrollment target
NCT01584648: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01584648 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 423 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01584648, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 423 participants
- Enrollment target
Study Summary
This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, and BRAF V600E/K mutation positive were screened for eligibility. Subjects who had prior systemic anti-cancer treatment in the advanced or metastatic setting were not eligible although prior systemic treatment in the adjuvant setting was allowed. Subjects were stratified according to the baseline lactate dehydrogenase level and BRAF genotype.
Primary Outcome
PFS is defined as the interval between the date of randomization and the earliest date of PD or death due to any cause. PD was based on radiographic or photographic evidence, and assessments were made by the investigator according to RECIST, version 1.1. PD is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. In addition, the sum must have an absolute increase from nadir of
Interventions
- DRUG Trametinib
- DRUG Dabrafenib
- DRUG Trametinib placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 423 participants |
| Start Date | 2012-05-04 |
| Est. Completion | 2019-02-28 |
| Phase | Phase 3 |
What the finished NCT01584648 record still lists
NCT01584648 is an interventional study that assigns participants to a tested intervention. The registered 423 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (45% lower).
The record links to 0 conditions, and to 3 interventions - of which Trametinib is the first listed.
NCT01584648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01584648 about?
NCT01584648 is a clinical study titled "A Study Comparing Trametinib and Dabrafenib Combination Therapy to Dabrafenib Monotherapy in Subjects With BRAF-mutant Melanoma". This was a two-arm, double-blinded, randomized, Phase III study comparing dabrafenib and trametinib combination therapy to dabrafenib administered with a placebo (dabrafenib monotherapy). Subjects with histologically confirmed cutaneous melanoma that is either Stage IIIC (unresectable) or Stage IV, ...
What is the current status of trial NCT01584648?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 423 participants. The study started on 2012-05-04. Estimated completion is 2019-02-28.
What interventions are being tested in trial NCT01584648?
The interventions under investigation include: Trametinib (DRUG), Dabrafenib (DRUG), Trametinib placebo (DRUG).
Who is sponsoring clinical trial NCT01584648?
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 NCT01584648's enrollment target sits among peer trials
423 885th of 2000 higher than 1,115 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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