Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Completed · Phase 2

Conditions studied: Urothelial Cancer

In brief

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

Key facts

Study ID

NCT00790426

Run by

Novartis Pharmaceuticals

People needed

44

Starts

2010-03-01

Expected to finish

2012-04-01

Last updated by the study team

2020-12-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California San Diego - Moores Cancer Center UCSD — La Jolla, California, United States
• USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3 — Los Angeles, California, United States
• University Chicago Hospital CTKI258A2201 — Chicago, Illinois, United States
• Dana Farber Cancer Institute Dana 1230 — Boston, Massachusetts, United States
• Nevada Cancer Institute Nevada Cancer Institute — Las Vegas, Nevada, United States
• Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2) — New York, New York, United States
• Duke University Medical Center Dept.ofDukeUniversityMedCtr(2) — Durham, North Carolina, United States
• The West Clinic — Memphis, Tennessee, United States
• Novartis Investigative Site — Vienna, Austria
• Novartis Investigative Site — Victoria, British Columbia, Canada
• Novartis Investigative Site — Toronto, Ontario, Canada
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Dresden, Germany
• Novartis Investigative Site — Ulm, Germany
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Seville, Andalusia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Catalonia, Spain
• Novartis Investigative Site — Barcelona, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Madrid, Spain
• Novartis Investigative Site — Tainan, Taiwan ROC, Taiwan
• Novartis Investigative Site — Taipei, Taiwan
• Novartis Investigative Site — Leeds, West Yorkshire, United Kingdom

Full record on ClinicalTrials.gov

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