Overview

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Withdrawn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.