Urothelial Cancer
Conditions
Keywords
Advanced urothelial cancer
Brief summary
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
Interventions
DRUGTKI258
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate | 4 Months |
| Progression free survival | 4 Months |
| overall survival | 4 Months |
Countries
Austria, Canada, Germany, Italy, Spain, Taiwan, United Kingdom, United States
Outcome results
None listed