A Randomised Phase II Trial of Methotrexate in Metastatic Colorectal Cancer With MSH2 Deficiency
The study will involve treating 29 subjects with methotrexate given intravenously. All
subjects will receive treatment; there is no control arm or randomisation. The subjects
will be known to have deficiency of MSH2, or a mutation (genetic change) in MSH2 that stops
it functioning normally. This can either be demonstrated by testing for loss of MSH2
protein in the tumour itself, or by the demonstration of a mutation in the MSH2 gene in the
subject's blood.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective response rate, to include complete response and partial response, as defined radiologically using RECIST (Response, Evaluation Criteria in Solid Tumours) on imaging CT scans performed during treatment.
United Kingdom: Medicines and Healthcare Products Regulatory Agency
CCR3107
NCT00952016
February 2009
July 2014
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