Last updated: 11/03/2018 16:34:51
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

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

GSK study ID
114375
Clinicaltrials.gov ID
NCT01376310
EudraCT ID
2010-023015-33
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: MEK114375: A Rollover Study to Provide Continued Treatment with GSK1120212 to Subjects with Solid Tumors and Leukemia
Trial description: This is an open-label study which will permit subjects with solid tumors or leukemia, who are currently clinically benefitting on another GSK sponsored trial with GSK1120212 either monotherapy or in combination continued access to GSK1120212.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

Number of participants with adverse events

Timeframe: 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.

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Everolimus + GSK1120212
  • Drug: Gemcitabine + GSK1120212
  • Drug: Carboplatin + GSK1120212
  • Drug: Docetaxel + GSK1120212
  • Drug: Nab-paclitaxel + GSK1120212
  • Drug: Erlotinib + GSK1120212
  • Drug: Pemetrexed + GSK1120212
  • Drug: GSK1120212
    • Enrollment:
    250
    Primary completion date:
    Not applicable
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Cancer, Neoplasms
    Product
    trametinib
    Collaborators
    Not applicable
    Study date(s)
    March 2011 to June 2018
    Type
    Interventional
    Phase
    1/2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • 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.
    • 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.
    Inclusion and exclusion 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. -

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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