GSK1120212 Rollover Study
Condition: Cancer
Intervention: GSK1120212; Docetaxel + GSK1120212; Erlotinib + GSK1120212; Pemetrexed + GSK1120212; Carboplatin + GSK1120212; Nab-paclitaxel + GSK1120212; Gemcitabine + GSK1120212; Everolimus + GSK1120212
Intervention description: up to 2 mg/day; dose as defined in the dose escalation protocol.; dose as defined in the dose escalation protocol.; dose as defined in the dose escalation protocol; dose as defined in the dose escalation protocol; dose as defined in the dose escalation protocol; dose as defined in the dose escalation protocol; dose as defined in the dose escalation protocol
Intervention MeSH terms: Paclitaxel; Docetaxel; Carboplatin; Gemcitabine; Pemetrexed; Everolimus; Erlotinib Hydrochloride; Trametinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 159.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.

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