Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors or Leukemia

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 159

Inclusion Criteria

A subject will be eligible for inclusion in this study only if all of the
following criteria apply:
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. Male subjects with a female partner of childbearing potential 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 16 weeks after the last dose of GSK1120212.
7. 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.
8. Female subjects of childbearing potential, as defined in parent study,
must have negative serum pregnancy tests at the time of transition to
this study.
9. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Subjects meeting any of the following criteria must not be enrolled in
this study:
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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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