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MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors and Leukemia


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer

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Trial Information

MEK114375: A Rollover Study to Provide Continued Treatment With GSK1120212 to Subjects With Solid Tumors and Leukemia


Inclusion Criteria:



1. Has provided signed informed consent for this study.

2. Has demonstrated compliance during the parent study with study treatment(s),
treatment visit schedules, and the requirements and restrictions listed in the
consent form.

3. Is currently participating in GSK1120212 study and is receiving treatment with
GSK1120212.

4. Is currently receiving clinical benefit as determined by the investigator from
previous treatment with GSK1120212 either as monotherapy or as part of a combination
treatment regimen.

5. Continued ability to swallow and retain orally administered study treatment(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.

6. Female subjects of childbearing potential, as defined in the parent study, must be
willing to continue practicing the same acceptable method of contraception as used in
the parent study during the rollover study and for at least 4 months after the last
dose of GSK1120212.

7. Female subjects of childbearing potential, as defined in parent study, must have
negative serum pregnancy tests at the time of transition to this study.

8. Subjects enrolled in France: 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:

1. Permanent discontinuation of GSK1120212 in the parent study due to toxicity or
disease progression.

2. Local access to commercially available GSK1120212.

3. Current use of a prohibitive medication(s) as listed in Section 6.2. NOTE: Use of
anticoagulants such as warfarin is permitted; however, the international
normalization ratio (INR) must be monitored in accordance with local institutional
practice.

4. Any unresolved toxicity that meets the study treatment discontinuation or study
withdrawal criteria from the parent study at the time of transition to this study.

5. Bazett-corrected QT (QTcB) interval ≥501 msec at the time of transition to this study

6. Left ventricular ejection fraction (LVEF) < institutional lower limit of normal (LLN)
by ECHO (preferred) or MUGA scan at the time of transition to this study.

7. Nursing female.

8. 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.

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Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with adverse events

Outcome Description:

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:

No

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

114375

NCT ID:

NCT01376310

Start Date:

March 2013

Completion Date:

October 2015

Related Keywords:

  • Cancer

Name

Location

GSK Investigational SitePhoenix, Arizona  85013 - 4496
GSK Investigational SiteFort Worth, Texas  76104
GSK Investigational SitePittsburgh, Pennsylvania  15213
GSK Investigational SiteGermantown, Tennessee  38138
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteAurora, Colorado  80012
GSK Investigational SiteSeattle, Washington  98133