Last updated: 11/03/2018 21:50:56
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study.

Evaluating Cardiomyopathy and Retinal Pigmented Epithelial Detachments (RPED) in Subjects Treated with GSK1120212 (MEKINIST) as Monotherapy or in Combination with Other Anticancer Therapies

GSK study ID
201711
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
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: Evaluating Cardiomyopathy and Retinal Pigmented Epithelial Detachments (RPED) in Subjects Treated with GSK1120212 (MEKINIST) as Monotherapy or in Combination with Other Anticancer Therapies
Trial description: An FDA Post-Marketing Requirement (PMR) to indentify and characterize the risk of serious sequelae of cardiomyopathy and to provide analyses to support dose modification and monitoring recommendations for cardiomyopathy in subjects using trametinib alone or in combination with dabrafenib. (MEKINIST® is a trademark of the GlaxoSmithKline group of companies)
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Safety

Timeframe: time varied thorugh 2020

Secondary outcomes:

None

Timeframe: NA

Interventions:
  • Other: Not Applicable
    • Enrollment:
    Not applicable
    Primary completion date:
    Not applicable
    Observational study model:
    Other
    Time perspective:
    Other
    Clinical publications:
    Not applicable
    Medical condition
    Melanoma
    Product
    trametinib
    Collaborators
    Not applicable
    Study date(s)
    August 2013 to September 2020
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Not applicable
    Age
    Not applicable
    Accepts healthy volunteers
    Not applicable
    • Data from the following Phase II and III randomized studies will be integrated: MEK114267/METRIC, MEK114653, MEK113487, BRF113220, MEK115306/COMBI-D, MEK116513/COMBI-V, BRF115532/COMBI-AD
    • Any additional GlaxoSmithKline (GSK) sponsored phase II or phase III randomized studies of trametinib either as monotherapy or in combination with other anti-cancer agents, which reach their primary analysis endpoint during the reporting time period will also be integrated and included in interim and final reports as appropriate
    • None
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Data from the following Phase II and III randomized studies will be integrated: MEK114267/METRIC, MEK114653, MEK113487, BRF113220, MEK115306/COMBI-D, MEK116513/COMBI-V, BRF115532/COMBI-AD
    • Any additional GlaxoSmithKline (GSK) sponsored phase II or phase III randomized studies of trametinib either as monotherapy or in combination with other anti-cancer agents, which reach their primary analysis endpoint during the reporting time period will also be integrated and included in interim and final reports as appropriate
    • All analyses will use the Safety population (SAFETY), which comprises all randomized subjects who received at least one dose of study medication and will be based on the actual treatment received if this differs from that to which the subject was randomized
    • Treatment arms will be combined as follows: 
    • Trametinib Monotherapy (treatment arms from MEK114267 and MEK114653);
    • Trametinib (2mg) plus Dabrafenib (150 mg) (treatment arms from BRF113220, MEK115306, MEK116513, and BRF115532);
    • Trametinib (1 mg) plus Dabrafenib (150 mg) (treatment arm from BRF113220); 
    • BRF Inhibitors (integrated dabrafenib control arm from BRF113220 and MEK115306 and Vemurafenib control arm from MEK116513); 
    • Trametinib plus Gemcitabine (treatment arm from MEK113487); 
    • Gemcitabine (control arm form MEK113487) 
    • Other Chemotherapy (DTIC & Paclitaxel control arm from MEK114267 and Docetaxel control arm from MEK114653);
    • Placebo (control arm from BRF115532)
    Exclusion criteria:
    • None

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

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

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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