Spots Global Cancer Trial Database for A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
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Trial Identification
Brief Title: A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
Official Title: A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
Study ID: NCT01231594
Conditions
Study Description
Brief Summary: 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
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
Novartis Investigative Site, New York, New York, United States
Novartis Investigative Site, New York, New York, United States
Novartis Investigative Site, Columbus, Ohio, United States
Novartis Investigative Site, Oklahoma City, Oklahoma, United States
Novartis Investigative Site, Philadelphia, Pennsylvania, United States
Novartis Investigative Site, Pittsburgh, Pennsylvania, United States
Novartis Investigative Site, Greenville, South Carolina, United States
Novartis Investigative Site, Memphis, Tennessee, United States
Novartis Investigative Site, Nashville, Tennessee, United States
Novartis Investigative Site, Nashville, Tennessee, United States
Novartis Investigative Site, Dallas, Texas, United States
Novartis Investigative Site, Houston, Texas, United States
Novartis Investigative Site, San Antonio, Texas, United States
Novartis Investigative Site, Salt Lake City, Utah, United States
Novartis Investigative Site, Tacoma, Washington, United States
Novartis Investigative Site, Randwick, New South Wales, Australia
Novartis Investigative Site, Westmead, New South Wales, Australia
Novartis Investigative Site, Adelaide, South Australia, Australia
Novartis Investigative Site, Heidelberg, Victoria, Australia
Novartis Investigative Site, Melbourne, Victoria, Australia
Novartis Investigative Site, Nedlands, Western Australia, Australia
Novartis Investigative Site, Toronto, Ontario, Canada
Novartis Investigative Site, Lille, , France
Novartis Investigative Site, Essen, Nordrhein-Westfalen, Germany
Novartis Investigative Site, Luebeck, Schleswig-Holstein, Germany
Novartis Investigative Site, Berlin, , Germany
Novartis Investigative Site, Napoli, Campania, Italy
Novartis Investigative Site, Konin, , Poland
Novartis Investigative Site, Warszawa, , Poland
Novartis Investigative Site, Barcelona, , Spain
Novartis Investigative Site, Madrid, , Spain
Novartis Investigative Site, Sevilla, , Spain
Novartis Investigative Site, Headington, , United Kingdom
Novartis Investigative Site, London, , United Kingdom
Contact Details
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
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