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

• Status: Withdrawn
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Trametinib

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.