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NCT01909453 · ClinicalTrials.gov registry record · Phase 3
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 921
- Enrollment target
NCT01909453 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 921 participants.
The verdict
NCT01909453, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 921 participants
- Enrollment target
Study Summary
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized. Part 1: Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms: 1. LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm) 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or 3. vemurafenib 960 mg BID (denoted as vemurafenib arm) Part 2: Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms: 1. LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or 2. LGX818 300 mg QD monotherapy (denoted as LGX818 arm)
Interventions
- DRUG MEK162
- DRUG LGX818
- DRUG vemurafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 921 participants |
| Start Date | 2013-09-12 |
| Est. Completion | 2024-09-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01909453
The ClinicalTrials.gov registry entry for NCT01909453 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 921 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MEK162 is the first listed.
NCT01909453 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01909453 about?
NCT01909453 is a clinical study titled "Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma". This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately ...
What is the current status of trial NCT01909453?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 921 participants. The study started on 2013-09-12. Estimated completion is 2024-09-03.
What interventions are being tested in trial NCT01909453?
The interventions under investigation include: MEK162 (DRUG), LGX818 (DRUG), vemurafenib (DRUG).
Who is sponsoring clinical trial NCT01909453?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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