GSK1120212 Rollover Study



Status:Terminated
Conditions:Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/21/2019
Start Date:November 2, 2010
End Date:January 18, 2018

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

This was an open-label study to permit subjects with solid tumors or leukemia, who were
clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or
in combination continued access to GSK1120212.


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. 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.

3. 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.

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

5. 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.

6. Nursing female.

7. 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
14
sites
Aurora, Colorado 80010
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Goodyear, Arizona 85338
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Goodyear, AZ
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Houston, Texas 77030
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Houston, TX
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Nashville, Tennessee 37205
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Nashville, TN
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New Haven, Connecticut
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New Haven, CT
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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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Philadelphia, Pennsylvania 19102
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Philadelphia, PA
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Sacramento, California 95825
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Sacramento, CA
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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
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
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San Antonio, TX
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Sarasota, Florida 34239
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Sarasota, FL
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Scottsdale, Arizona 85251
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Scottsdale, AZ
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Tacoma, Washington 98405
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Tacoma, WA
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Toronto, Ontario
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Toronto,
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