SelPac Version 1
Research type
Research Study
Full title
A Randomised three-arm, open label, Phase II study of continuous Selumetinib versus continuous or interrupted Selumetinib in combination with weekly Paclitaxel in metastatic Uveal Melanoma
IRAS ID
169996
Contact name
Paul Nathan
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2014-004437-22
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Uveal melanoma is the most common primary cancer involving the eye and is characterised by an unpredictable clinical course and a tendency to metastasise (spread). Control of the primary cancer in the eye can be achieved using various radiotherapy techniques or removal of the affected eye. However, once control of the primary cancer in the eye is lost and cancer has spread to other areas in the body, the disease is incurable. 50% of all patients will relapse with metastatic disease and unfortunately the prognosis for relapsed patients is poor with a median overall survival (OS) of approximately 6 months. There is an urgent need for novel therapies for advanced disease to be investigated.
Recently, inhibition of a protein called MEK has been shown to have clinical activity in the palliative treatment of advanced disease and it is likely that MEK inhibitors will become a standard of care. This trial will assess the relative merits of a MEK inhibitor called Selumetinib, taken alone or in combination with paclitaxel chemotherapy in one of two schedules.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/0159
Date of REC Opinion
8 Apr 2015
REC opinion
Further Information Favourable Opinion