This rollover study is designed to provide continued access to GSK2118436 for eligible subjects with BRAF mutation-positive tumors who have previously participated in a GlaxoSmithKline (GSK)-sponsored GSK2118436 study (parent study), who have no evidence of progressive disease and who have tolerated GSK2118436 in the parent study without significant toxicities. Subjects will be enrolled into the appropriate cohort based upon the treatment received in their parent study. Safety assessments (physical examinations, vital signs, 12-lead electrocardiograms, echocardiograms, clinical laboratory assessments, and monitoring of adverse events) will be made throughout the study. Clinical activity will be assessed using local standard of care imaging practices and the appropriate response criteria as determined by the investigator.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Study Drug
Study Drug
Study Drug
Novartis Investigative Site
Goodyear, Arizona, United States
Novartis Investigative Site
Scottsdale, Arizona, United States
Novartis Investigative Site
Tucson, Arizona, United States
Novartis Investigative Site
Los Angeles, California, United States
Novartis Investigative Site
Los Angeles, California, United States
Number of participants with adverse events, as a measure of safety and tolerability
Time frame: From date of transition into this Rollover study until 28 days following the last dose. Subjects may continue to receive study medication until disease progression, death or unacceptable adverse event; there is no time limit for this outcome measure.
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Novartis Investigative Site
San Francisco, California, United States
Novartis Investigative Site
Sarasota, Florida, United States
Novartis Investigative Site
Ann Arbor, Michigan, United States
Novartis Investigative Site
Detroit, Michigan, United States
Novartis Investigative Site
Lebanon, New Hampshire, United States
...and 34 more locations