Clinical trial NCT00790426: Phase II Study of TKI258 in Advanced Urothelial Carcinoma
Official title: A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Urothelial Cancer
Keywords: Advanced urothelial cancer
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-11-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Overall response rate
timeFrame: 4 months
Secondary outcomes:
measure: Disease control rate
timeFrame: 4 Months
measure: Progression free survival
timeFrame: 4 Months
measure: overall survival
timeFrame: 4 Months
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego - Moores Cancer Center UCSD
state: California
city: Los Angeles
country: United States
facility: USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
state: California
city: Chicago
country: United States
facility: University Chicago Hospital CTKI258A2201
state: Illinois
city: Boston
country: United States
facility: Dana Farber Cancer Institute Dana 1230
state: Massachusetts
city: Las Vegas
country: United States
facility: Nevada Cancer Institute Nevada Cancer Institute
state: Nevada
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
state: New York
city: Durham
country: United States
facility: Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
state: North Carolina
city: Memphis
country: United States
facility: The West Clinic
state: Tennessee
city: Vienna
country: Austria
facility: Novartis Investigative Site
city: Victoria
country: Canada
facility: Novartis Investigative Site
state: British Columbia
city: Toronto
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Ulm
country: Germany
facility: Novartis Investigative Site
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Sevilla
country: Spain
facility: Novartis Investigative Site
state: Andalucia
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
state: Catalunya
city: Barcelona
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Madrid
country: Spain
facility: Novartis Investigative Site
city: Tainan 704
country: Taiwan
facility: Novartis Investigative Site
state: Taiwan ROC
city: Taipei
country: Taiwan
facility: Novartis Investigative Site
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.