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Phase II Study of TKI258 in Advanced Urothelial Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00790426
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : December 19, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE November 10, 2008
First Posted Date  ICMJE November 13, 2008
Last Update Posted Date December 19, 2020
Study Start Date  ICMJE March 2010
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
Overall response rate [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2008)
Progression free survival [ Time Frame: 8 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 25, 2009)
  • Disease control rate [ Time Frame: 4 Months ]
  • Progression free survival [ Time Frame: 4 Months ]
  • overall survival [ Time Frame: 4 Months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2008)
Safety Profile [ Time Frame: Every Visit ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Phase II Study of TKI258 in Advanced Urothelial Carcinoma
Official Title  ICMJE A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
Brief Summary This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urothelial Cancer
Intervention  ICMJE Drug: TKI258
Study Arms  ICMJE
  • Experimental: FGFR3 wild type
    Intervention: Drug: TKI258
  • Experimental: FGFR3 mutant
    Intervention: Drug: TKI258
Publications * Milowsky MI, Dittrich C, Durán 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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 18, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2008)
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Canada,   Germany,   Italy,   Spain,   Taiwan,   United Kingdom,   United States
Removed Location Countries Netherlands
Administrative Information
NCT Number  ICMJE NCT00790426
Other Study ID Numbers  ICMJE CTKI258A2201
2008-005870-11 ( EudraCT Number )
EudraCT 2008-005870-11
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP