Cancer, GNA11 Mutation-positive Metastatic Melanoma, GNAQ Mutation-positive Metastatic Melanoma, Metastatic Uveal Melanoma
Conditions
Brief summary
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.
Interventions
DRUGGSK1120212
Repeating oral dose
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate as assessed by RECIST v1.1 | At least 12 weeks after initiating study treatment |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response, progression free survival, overall survival | Through study completion or early study discontinuation |
| Safety, tolerability, and population pharmacokinetic parameters | Through study completion or early study discontinuation |
Outcome results
None listed