The purpose of this study is to find out what effects, good and/or bad, intermittent dosing
of the drug Selumetinib will have on subjects with uveal melanoma. Selumetinib is a drug that
blocks (or turns off) methyl ethyl ketone (MEK), a protein activated in some uveal melanoma
cells. Selumetinib is a MEK inhibitor. Blocking MEK may stop the cancer from growing.
Uveal melanoma (UM) is the most common primary intraocular malignancy in adults, and arises
from melanocytes within the choroid plexus of the eye. The development of metastasis is
common and occurs in approximately 50% of patients with posterior UM within 15 years of
initial diagnosis and treatment. As no effective systemic therapy has yet been identified for
this disease, outcomes for metastatic UM are poor with a median survival of 12 months.
There is no FDA approved therapy for patients with advanced UM. Studies have shown that
inhibition of the Mitogen-activated protein kinase (MAPK) pathway with the MEK inhibitor
selumetinib (hyd-sulfate AZD6244) is an effective therapy for uveal melanoma but despite this
treatment, cures are not achieved. Although drugs such as selumetinib have been studied when
patients take the treatment every day, research has shown that in some cases, it may be
better to use the treatment on an intermittent schedule. Such a strategy may reduce the side
effects, allow higher doses of the drug to be used, more completely block the MAPK pathway,
and prevent the development of drug resistance mechanisms within the tumor.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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