BACKGROUND: @entity42122 is a novel, direct-acting and specific inhibitor of thymidylate synthase that has shown clinical activity and manageable tolerability in solid @entity5 . This phase II trial was designed to determine the antitumour activity and tolerability of @entity42122 given as a first-line therapy to @entity1 with advanced @entity356 . @entity1 AND METHODS: Eligible @entity1 who were chemona  ve with histologically or cytologically proven @entity356 entered an open-label, multicentre, two-stage trial. Initially, @entity1 were dosed at 130 mg/m2 (Regimen 1); however, following a protocol amendment, the starting dose was reduced to 65 mg/m2 (Regimen 2). @entity1 received @entity42122 as a 30-min i.v. infusion once weekly for 2 weeks followed by 1 week without treatment (3-week cycle). RESULTS: Twenty-nine @entity1 with advanced, relapsed or inoperable @entity356 were recruited from 11 centres across Europe. Five @entity1 (17.2%), all from Regimen 2, showed a partial response and 16 @entity1 (55.2%) had a best response of disease stabilisation. Most @entity1 (72.4%) had a best response of disease control with median time to progression being 98 days. @entity42122 had manageable @entity137 with the most frequently reported adverse events being @entity1398 (62%) and @entity294 (38%). CONCLUSIONS: @entity42122 , as a first-line treatment for @entity1 with advanced @entity356 , demonstrated clinical activity and manageable @entity137 .

Phase II multicentre trial of @entity42122 monotherapy as first-line treatment for XXXX .

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients', 'PATIENTS'] @entity137 :: ('MESH:D064420', 'Disease') :: ['toxicity'] @entity42122 :: ('MESH:C094299', 'Chemical') :: ['ZD9331'] @entity5 :: ('MESH:D009369', 'Disease') :: ['tumours'] @entity294 :: ('MESH:D003967', 'Disease') :: ['diarrhoea'] @entity1398 :: ('MESH:D009503', 'Disease') :: ['neutropenia'] @entity356 :: ('MESH:D013274', 'Disease') :: ['gastric cancer']
@entity356 :: (MESH:D013274,Disease) :: ['gastric cancer']
