Phase II Study of TKI258 in Advanced Urothelial Carcinoma

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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