A Rollover Study to Provide Continued Treatment With GSK2118436 to Subjects With BRAF Mutation-Positive Tumors



Status:Completed
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/24/2019
Start Date:November 5, 2010
End Date:April 9, 2018

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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.


Inclusion Criteria:

- Has provided signed written informed consent for this study

- 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:

- Permanent discontinuation of GSK2118436 in the parent study due to toxicity or disease
progression

- 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) (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
We found this trial at
23
sites
Ann Arbor, Michigan 48109
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Columbus, Ohio 43205
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Dallas, Texas 75216
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Detroit, Michigan 48202
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Detroit, MI
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Goodyear, Arizona 85338
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Goodyear, AZ
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Greenville, South Carolina 29605
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Greenville, SC
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Houston, Texas 77030
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Houston, TX
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Lebanon, New Hampshire 03756
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Los Angeles, California 90095
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Los Angeles, CA
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Memphis, Tennessee 38120
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Memphis, TN
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Nashville, Tennessee 37205
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Nashville, TN
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Pittsburgh, Pennsylvania 15224
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Pittsburgh, PA
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Randwick, New South Wales 2031
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Randwick,
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Salt Lake City, Utah 84103
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Salt Lake City, UT
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San Antonio, Texas 78207
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San Francisco, California 94121
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San Francisco, CA
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Sarasota, Florida 34239
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Sarasota, FL
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Scottsdale, Arizona 85251
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Tacoma, Washington 98405
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Tucson, Arizona 85745
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Tucson, AZ
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