Phase II Study of TKI258 in Advanced Urothelial Carcinoma

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

This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer

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