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NCT01266967 · ClinicalTrials.gov registry record · Phase 2
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 172
- Enrollment target
NCT01266967: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01266967 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 172 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01266967, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 172 participants
- Enrollment target
Study Summary
This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brain therapy, and subjects in Cohort B will have received prior local therapy for brain metastases. Subjects will continue on treatment until disease progression, death, or unacceptable adverse event.
Primary Outcome
OIR is defined as the number of participants whose intracranial response was a confirmed complete response (CR) or partial response (PR) assessed by investigators using modified Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. CR is defined as disappearance of all lesions. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters (e.g., percent change from Baseline). For the primary analysis
Interventions
- DRUG GSK2118436
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2011-02 |
| Est. Completion | 2012-11 |
| Phase | Phase 2 |
What the finished NCT01266967 record still lists
NCT01266967 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (29% higher).
The record links to 0 conditions, and to 1 intervention - of which GSK2118436 is the first listed.
NCT01266967 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01266967 about?
NCT01266967 is a clinical study titled "A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma to the Brain". This study is designed to assess the efficacy, pharmacokinetics, safety, and tolerability of an oral, twice daily dose of 150 mg GSK2118436 administered to subjects with BRAF V600E or V600K mutation-positive metastatic melanoma to the brain. Subjects in Cohort A will not have received any local brai...
What is the current status of trial NCT01266967?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2011-02. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01266967?
The interventions under investigation include: GSK2118436 (DRUG).
Who is sponsoring clinical trial NCT01266967?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01266967's enrollment target sits among peer trials
172 397th of 2000 higher than 1,603 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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