A Phase III Randomized, Open-label Study Comparing GSK1120212 to Chemotherapy in Subjects With Advanced or Metastatic BRAF V600E/K Mutation-positive Melanoma
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free Survival in BRAF V600E Mutation-positive Participants Without a History of Brain Metastases as Assessed by the Investigator and Independent Review
Progression-free survival (PFS) is defined as the time from randomization to the first documented occurrence of disease progression 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 patients improve (respond), stay the same (stabilize), or worsen (progress) during treatment. Disease progression is defined as at least a 20% increase in the sum of the diameters of target lesions with an absolute increase of at least 5 millimeters (mm) or the appearance of at least 1 new lesion, or the worsening of non-target lesions significant enough to require study treatment discontinuation.
Day 1 until the earliest date of disease progression or death due to any cause (average of 4.8 months)
No
GSK Clinical Trials
Study Director
GlaxoSmithKline
Australia: Human Research Ethics Committee
114267
NCT01245062
November 2010
March 2013
Name | Location |
---|---|
GSK Investigational Site | Phoenix, Arizona 85013 - 4496 |
GSK Investigational Site | Gainesville, Florida 32610 |
GSK Investigational Site | New Orleans, Louisiana 70112 |
GSK Investigational Site | Springfield, Massachusetts 01107 |
GSK Investigational Site | Akron, Ohio 44304 |
GSK Investigational Site | Savannah, Georgia 31405 |
GSK Investigational Site | Bettendorf, Iowa 52722 |
GSK Investigational Site | Columbia, South Carolina 29210 |
GSK Investigational Site | Germantown, Tennessee 38138 |
GSK Investigational Site | Edison, New Jersey 08837 |