GSK1120212 vs Chemotherapy in Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Public ClinicalTrials.gov record NCT01245062. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01245062
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 322 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 21, 2010
- Primary completion
- Oct 25, 2011
- Completion
- Dec 15, 2016
- Last update posted
- Apr 4, 2018
2010 – 2016
United States locations
- U.S. sites
- 13
- U.S. states
- 10
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Tucson | Arizona | 85724-5024 | — |
| GSK Investigational Site | Fort Myers | Florida | 33916 | — |
| GSK Investigational Site | Athens | Georgia | 30607 | — |
| GSK Investigational Site | Marietta | Georgia | 30060 | — |
| GSK Investigational Site | Iowa City | Iowa | 52242 | — |
| GSK Investigational Site | Metairie | Louisiana | 70006 | — |
| GSK Investigational Site | Boston | Massachusetts | 02114 | — |
| GSK Investigational Site | Morristown | New Jersey | 07962-1956 | — |
| GSK Investigational Site | Columbus | Ohio | 43210 | — |
| GSK Investigational Site | Columbia | South Carolina | 29210 | — |
| GSK Investigational Site | Chattanooga | Tennessee | 37404 | — |
| GSK Investigational Site | Memphis | Tennessee | 38120 | — |
| GSK Investigational Site | Nashville | Tennessee | 37203 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 99 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01245062, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2018 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01245062 live on ClinicalTrials.gov.