A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors
NCT ID: NCT01231594
Last Updated: 2019-03-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
214 participants
INTERVENTIONAL
2010-11-05
2018-04-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A
Subjects who have received \</= 8 weeks of GSK2118436 monotherapy in the parent study
GSK2118436
Study Drug
Cohort B
Subjects who have received \>8 weeks of continuous treatment with GSK2118436 either as monotherapy or combination therapy with another approved anti-cancer agent
GSK2118436
Study Drug
Other approved anti-cancer agent
Study Drug
Cohort C
Subjects who have received \>8 weeks of continuous treatment with GSK2118436 in combination with a MEK inhibitor, GSK1120212
GSK2118436
Study Drug
GSK1120212
Study Drug
Interventions
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GSK2118436
Study Drug
GSK1120212
Study Drug
Other approved anti-cancer agent
Study Drug
Eligibility Criteria
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Inclusion Criteria
* Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
* Is currently participating in a GSK-sponsored study of GSK2118436
* Currently has no evidence of progressive disease, as determined by the investigator, following previous treatment with GSK2118436 (either as monotherapy or as part of a combination treatment regimen)
* For Cohort C only: Subjects must have a calcium phosphate product (CPP) of \<4.4 mmol\^2/L\^2 (55 mg\^2/dL\^2) if they are to continue treatment with GSK1120212
* Continued ability to swallow and retain orally administered study drug(s) and does not have any clinically significant GI abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels
* Women of childbearing potential and men with reproductive potential must be willing to continue practicing acceptable methods of birth control during the study NOTE: Oral contraceptives are not reliable due to potential drug-drug interaction with GSK2118436
* Women of childbearing potential must have a negative serum pregnancy test at the time of transition to this study and before the first dose of study treatment
* French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion Criteria
* Local access to commercially available GSK2118436
* Currently receiving treatment with any prohibited medication(s)
* Any unresolved toxicity \> Grade 2 (National Cancer Institute-Common Toxicity Criteria for Adverse Events \[NCI-CTCAE\], version 4.0) from parent study treatment, except for alopecia, will need to be approved by the GSK Medical Monitor
* Uncontrolled diabetes, hypertension or other medical conditions at the time of transition to this study that may interfere with assessment of toxicity
* Presence of rheumatoid arthritis
* Corrected QT (QTc) interval \>/= 480 msec at the time of transition to this study
* Left ventricular ejection fraction (LVEF) \</= institutional lower limit of normal (LLN) by ECHO at the time of transition to this study
* Class II, III, or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system at the time of transition to this study
* Pregnant or lactating female
* Any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or GSK Medical Monitor
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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, North Rhine-Westphalia, Germany
Novartis Investigative Site
Lübeck, Schleswig-Holstein, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Napoli, Campania, Italy
Novartis Investigative Site
Konin, , Poland
Novartis Investigative Site
Warsaw, , Poland
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Madrid, , Spain
Novartis Investigative Site
Seville, , Spain
Novartis Investigative Site
Headington, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Countries
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Other Identifiers
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114144
Identifier Type: -
Identifier Source: org_study_id
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