Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Inclusion Criteria: * Patients with transitional cell cancer of the bladder, urethra, ureter, or renal pelvis * Patients who have archival tumor tissue available for FGFR3 mutational status screening * Patients with progressive disease * Patients with measurable disease by RECIST * Patients previously treated with at least 1 but not more than 3 systemic cytotoxic regimens with at least one of these regimens including at least one of the following: cisplatin, carboplatin, gemcitabine or taxane administered in the perioperative or advanced setting * Age ≥ 18 years * WHO Performance Status ≤ 2 * Patients willing and able to take oral medication, follow scheduled visits, treatment plan and laboratory tests * Patients with signed and witnessed informed consent form * Patients with adequate organ function Exclusion Criteria: * Patients with brain cancer * Patients with other cancers except for certain skin, cervical \& prostate cancers * Patients who have not recovered from previous cancer treatment * Patients who have severe and/or uncontrolled medical conditions which could affect participation in the study Other protocol-defined inclusion/exclusion criteria may apply