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NCT01245062 · ClinicalTrials.gov registry record · Phase 3
GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
A Phase 3 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 3
- Development phase
- 322
- Enrollment target
NCT01245062: Completed Phase 3 study, sponsored by GlaxoSmithKline.
NCT01245062 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 322 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01245062, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 322 participants
- Enrollment target
Study Summary
This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have received up to one prior regimen of chemotherapy in the advanced or metastatic melanoma setting will be enrolled into the study. Subjects with any prior BRAF or MEK inhibitor use will be excluded. Approximately 297 subjects will be enrolled with 2:1 randomization (198 subjects into the GSK1120212 arm and 99 subjects into the chemotherapy arm). The primary endpoint for the statistical analysis will be a comparison of progression free survival for subjects receiving GSK1120212 compared to chemotherapy. Subjects who have progression on chemotherapy will be offered the option to receive GSK1120212.
Primary Outcome
Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression (PD) or death. PFS for investigator-assessed and blinded, independent, central review committee (BRIC)-assessed responses was summarized per Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, which is a set of published rules defining when cancer participants improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Diseas
Interventions
- DRUG Chemotherapy
- DRUG GSK1120212
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 322 participants |
| Start Date | 2010-11-22 |
| Est. Completion | 2016-12-16 |
| Phase | Phase 3 |
What the finished NCT01245062 record still lists
NCT01245062 is an interventional study that assigns participants to a tested intervention. The registered 322 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 (58% lower).
The record links to 0 conditions, and to 2 interventions - of which Chemotherapy is the first listed.
NCT01245062 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01245062 about?
NCT01245062 is a clinical study titled "GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma". This is a two-arm, open-label, randomized Phase III study comparing single agent GSK1120212 to chemotherapy (either dacarbazine or paclitaxel) in subjects with Stage IIIc or Stage IV malignant cutaneous melanoma. All subjects must have a BRAF mutation-positive tumour sample. Subjects who have receiv...
What is the current status of trial NCT01245062?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 322 participants. The study started on 2010-11-22. Estimated completion is 2016-12-16.
What interventions are being tested in trial NCT01245062?
The interventions under investigation include: Chemotherapy (DRUG), GSK1120212 (DRUG).
Who is sponsoring clinical trial NCT01245062?
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 NCT01245062's enrollment target sits among peer trials
322 1081st of 2000 higher than 920 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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