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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 423 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01584648
The ClinicalTrials.gov registry entry for NCT01584648 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 423 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trametinib is the first listed.
NCT01584648 reports 0 study locations.
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.
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