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
- 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
- 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
- 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
- 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
- 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
- History of clinically significant cardiac or pulmonary dysfunction.
- Allergy or hypersensitivity to components of the GSK1120212 formulation.
- The patient is pregnant or breastfeeding.