Status:
COMPLETED
Phase II Study of TKI258 in Advanced Urothelial Carcinoma
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Urothelial Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00790426
Start Date
March 1 2010
End Date
April 1 2012
Last Update
December 19 2020
Active Locations (26)
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1
University of California San Diego - Moores Cancer Center UCSD
La Jolla, California, United States, 92093-0658
2
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, United States, 90053
3
University Chicago Hospital CTKI258A2201
Chicago, Illinois, United States, 60637
4
Dana Farber Cancer Institute Dana 1230
Boston, Massachusetts, United States, 02215