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