Phase II Study of TKI258 in Advanced Urothelial Carcinoma
NCT ID: NCT00790426
Last Updated: 2020-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
44 participants
INTERVENTIONAL
2010-03-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FGFR3 wild type
TKI258
FGFR3 mutant
TKI258
Interventions
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TKI258
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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 City, Taiwan ROC, Taiwan
Novartis Investigative Site
Taipei, , Taiwan
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom
Novartis Investigative Site
Southampton, , United Kingdom
Countries
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References
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Milowsky MI, Dittrich C, Duran I, Jagdev S, Millard FE, Sweeney CJ, Bajorin D, Cerbone L, Quinn DI, Stadler WM, Rosenberg JE, Lochheed M, Sen P, Squires M, Shi M, Sternberg CN. Phase 2 trial of dovitinib in patients with progressive FGFR3-mutated or FGFR3 wild-type advanced urothelial carcinoma. Eur J Cancer. 2014 Dec;50(18):3145-52. doi: 10.1016/j.ejca.2014.10.013. Epub 2014 Oct 30.
Related Links
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Results for CTKI258A2201 from the Novartis Clinical Trials website
Other Identifiers
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2008-005870-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EudraCT 2008-005870-11
Identifier Type: -
Identifier Source: secondary_id
CTKI258A2201
Identifier Type: -
Identifier Source: org_study_id