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NCT01153763 · ClinicalTrials.gov registry record · Phase 2
A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma
A Phase 2 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 92
- Enrollment target
NCT01153763: Completed Phase 2 study, sponsored by GlaxoSmithKline.
NCT01153763 is a Phase 2 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 92 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01153763, a Phase 2 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 92 participants
- Enrollment target
Study Summary
BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
Primary Outcome
A participant was defined as a responder if he/she achieved either a CR (the disappearance of all target lesions. Any pathological lymph nodes must be \<10 millimeter (mm) in the short axis.) or PR (at least a 30 percent decrease in the sum of the diameters of target lesions, taking as a reference, the Baseline sum of the diameters \[e.g., percent change from Baseline\]). To be assigned a status of PR or CR, a confirmatory disease assessment was required at Week 12 if an initial response was see
Interventions
- DRUG GSK2118436
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 92 participants |
| Start Date | 2010-08-09 |
| Est. Completion | 2016-06-01 |
| Phase | Phase 2 |
What the finished NCT01153763 record still lists
NCT01153763 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 92 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (31% lower).
The record links to 0 conditions, and to 1 intervention - of which GSK2118436 is the first listed.
NCT01153763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01153763 about?
NCT01153763 is a clinical study titled "A Study of GSK2118436 in BRAF Mutant Metastatic Melanoma". BRF113710 is a Phase II, single-arm, open-label study to assess the efficacy, safety, and tolerability of GSK2118436 administered twice daily as a single agent in subjects with BRAF mutant metastatic melanoma. Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until dis...
What is the current status of trial NCT01153763?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 92 participants. The study started on 2010-08-09. Estimated completion is 2016-06-01.
What interventions are being tested in trial NCT01153763?
The interventions under investigation include: GSK2118436 (DRUG).
Who is sponsoring clinical trial NCT01153763?
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 NCT01153763's enrollment target sits among peer trials
92 767th of 2000 higher than 1,230 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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