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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events, as a measure of safety and tolerability

Outcome 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.

Safety Issue:

Yes

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

114144

NCT ID:

NCT01231594

Start Date:

November 2010

Completion Date:

August 2016

Related Keywords:

  • Cancer
  • BRAF Inhibitor
  • Cancer
  • Safety
  • GSK2118436
  • BRAF mutation positive tumors

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SiteRoyal Oak, Michigan  48073
GSK Investigational SiteOklahoma City, Oklahoma  73112
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteColumbia, South Carolina  29210
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteSalt Lake City, Utah  84107
GSK Investigational SiteSeattle, Washington  98133