Clinical Trials

The James Cancer Center Columbus, OH

open for enrollment

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

Protocol: OSU-11024

Full Title

BRF114144: A Rollover Study to Provide Continued Treatment with GSK2118436 to Subjects with BRAF Mutation-Positive Tumor

Purpose

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.

Are you eligible?

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) </= 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