TKI258 in advanced urothelial carcinoma
Research type
Research Study
Full title
A Phase II multi-center, non-randomized, open-label study of TKI258 in patients with either FGFR3 mutated or FGFR3 wild type advanced urothelial carcinoma
IRAS ID
41004
Contact name
John Chester
Sponsor organisation
Novartis Pharma Services AG
Eudract number
2008-005870-11
Clinicaltrials.gov Identifier
Research summary
TKI258 belongs to a class of drugs known as tyrosine kinase receptor inhibitors. In laboratory studies, TKI258 has been shown to shrink or slow the growth of several different types of tumour types. The purpose of this study is to determine the anti-tumour activity and safety profile of TKI258 when given to patients with advanced urothelial cancer known to have normal and mutated (changed) FGFR3. All patients in the study will be given TKI258. They will receive the treatment orally for 5 consecutive days, followed by 2 days rest period for as long as they and their study doctor feels that they are benefiting. Patients will be monitored closely throughout the treatment period by trained doctors and nurses who specialise in bladder cancer research and treatment.
REC name
North East - York Research Ethics Committee
REC reference
10/H0903/5
Date of REC Opinion
8 Mar 2010
REC opinion
Further Information Favourable Opinion