A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type 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