Phase II Study of TKI258 in Advanced Urothelial Carcinoma
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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