A Phase I/IIa Trial of AZD4547 in combination with CX
Research type
Research Study
Full title
A Phase I/IIa trial of AZD4547 in combination with Cisplatin and Capecitabine (CX)
IRAS ID
75031
Contact name
Thomas Ronald Jeffry Evans
Contact email
Eudract number
2011-000642-37
ISRCTN Number
66171897
Research summary
Genetic modifications of the FGF receptors, including amplifications, translocations, and mutations, have been described in a range of tumours, including polysomy or amplification of FGFR2 in approximately 30 ?? 40% of gastric cancer patients. Pre-clinical data indicate that the presence of these changes can confer sensitivity to FGFR inhibitors. AZD4547 is a potent and selective inhibitor of fibroblast growth factor receptor (FGFR) 1, 2, and 3 receptor tyrosine kinases. Cisplatin and capecitabine are established agents that are given in combination in the treatment of a number of cancers, including advanced gastro-oesophageal cancer. However, clinical outcome with this regimen remains disappointing in patients with advanced gastro-oesophageal cancer, with a median overall survival of 9 ?? 11 months. The aims of this study are (a) to determine the safety, tolerability, and recommended dose of AZD4547 when administered in combination with cisplatin and capecitabine (CX) in patients with advanced refractory cancers, and pharmacokinetic (PK) and pharmacodynamic (PD) studies will also be performed; and (b) to compare the effects of AZD4547-CX versus CX-placebo on progression-free survival, objective response rates, overall survival, and pharmacodynamic studies, when administered to patients with locally advanced or metastatic gastro-oesophageal adenocarcinoma and with FGFR2 polysomy or amplification (FISH 4/5 or FISH 6).
REC name
West of Scotland REC 1
REC reference
11/WS/0039
Date of REC Opinion
18 Oct 2011
REC opinion
Further Information Favourable Opinion