Last updated: 11/03/2018 16:13:46

Efficacy and Safety Study of GSK1120212, a MEK Inhibitor, in Subjects with Uveal Melanoma

GSK study ID
114091
Clinicaltrials.gov ID
NCT01328106
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: A Single-Arm, Open-Label, Multi-Center Study to Investigate the Objective Response Rate, Safety, and Pharmacokinetics of GSK1120212, a MEK Inhibitor, in Subjects with Metastatic Uveal Melanoma or with Mutation-Positive GNAQ or GNA11 Metastatic Melanoma
Trial description: The purpose of this study is to determine whether GSK1120212, a MEK inhibitor, is an effective and safe treatment for cancer subjects with metastatic uveal melanoma and mutation-positive GNAQ or GNA11 metastatic melanoma.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
None
Primary outcomes:

Objective response rate as assessed by RECIST v1.1

Timeframe: At least 12 weeks after initiating study treatment

Secondary outcomes:

Duration of response, progression free survival, overall survival

Timeframe: Through study completion or early study discontinuation

Safety, tolerability, and population pharmacokinetic parameters

Timeframe: Through study completion or early study discontinuation

Interventions:
  • Drug: GSK1120212
    • Enrollment:
    0
    Primary completion date:
    2011-15-08
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    GNA11 mutation-positive metastatic melanoma, Cancer
    Product
    trametinib
    Collaborators
    Not applicable
    Study date(s)
    November 2010 to May 2012
    Type
    Interventional
    Phase
    2

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
    • Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
    • The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
    • The patient has received experimental therapy within 21 days of starting study drug.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Histologically or cytologically confirmed diagnosis of metastatic uveal melanoma or previously documented mutation-positive GNAQ or GNA11 metastatic melanoma not previously treated with a MEK inhibitor.
    • Provide archival tumor tissue or, if tissue blocks are not available, undergo fresh tumor biopsy prior to enrollment.
    • The patient has a radiographically measurable tumor.
    • ECOG performance status 0, 1, or 2.
    • The patient is able to swallow and retain oral medication.
    • Life expectancy of at least 4 months.
    • Toxicities from previous anti-cancer therapy (except alopecia) are recovered (Grade 1 or less) at the time of enrollment.
    • The patient has adequate organ and bone marrow function.
    • Sexually active patients must use medically acceptable methods of contraception during the course of the study.
    • Female patients of childbearing potential must have a negative serum pregnancy test at screening.
    Exclusion criteria:
    • The patient has had any of the following within 21 days of starting study drug or anticipates the need for any of the following during the course of study treatment: chemotherapy, immunotherapy, biologic therapy, hormone therapy, major surgery, or tumor embolization.
    • The patient has received experimental therapy within 21 days of starting study drug.
    • The patient has received nitrosourea or mitomycin C within 42 days of starting study drug.
    • The patient has received any herbal medications or palliative radiotherapy within 14 days of starting study drug.
    • The patient is currently receiving anticoagulation therapy that is not well controlled.
    • Ongoing or newly diagnosed eye abnormality other than symptoms due to uveal melanoma.
    • History of retinal vein occlusion or central serous retinopathy.
    • Current severe, uncontrolled systemic disease.
    • History of leptomeningeal disease or spinal cord compression secondary to metastasis.
    • Brain metastasis, unless previously treated with surgery, whole-brain radiation or stereotactic radiosurgery and the disease has been stable for at least 3 months without steroid use or on a stable dose of steroids for at least 1 month prior to starting study drug. Stability of brain metastases must be confirmed with imaging.
    • The patient has a concurrent, active hematological malignancy or other solid tumor malignancy.
    • History of clinically significant cardiac or pulmonary dysfunction.
    • Allergy or hypersensitivity to components of the GSK1120212 formulation.
    • The patient is pregnant or breastfeeding.

    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
    Other
    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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