Working… Menu

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 )

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

Condition or disease Intervention/treatment Phase
Urothelial Cancer Drug: TKI258 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2010
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FGFR3 wild type Drug: TKI258
Experimental: FGFR3 mutant Drug: TKI258

Primary Outcome Measures :
  1. Overall response rate [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Disease control rate [ Time Frame: 4 Months ]
  2. Progression free survival [ Time Frame: 4 Months ]
  3. overall survival [ Time Frame: 4 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00790426

Layout table for location information
United States, California
University of California San Diego - Moores Cancer Center UCSD
La Jolla, California, United States, 92093-0658
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, United States, 90053
United States, Illinois
University Chicago Hospital CTKI258A2201
Chicago, Illinois, United States, 60637
United States, Massachusetts
Dana Farber Cancer Institute Dana 1230
Boston, Massachusetts, United States, 02215
United States, Nevada
Nevada Cancer Institute Nevada Cancer Institute
Las Vegas, Nevada, United States, 89135
United States, New York
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
New York, New York, United States, 10065
United States, North Carolina
Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
Durham, North Carolina, United States, 27710
United States, Tennessee
The West Clinic
Memphis, Tennessee, United States, 38120
Novartis Investigative Site
Vienna, Austria, 1100
Canada, British Columbia
Novartis Investigative Site
Victoria, British Columbia, Canada, V8R 6V5
Canada, Ontario
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Ulm, Germany, 89081
Novartis Investigative Site
Roma, RM, Italy, 00152
Novartis Investigative Site
Sevilla, Andalucia, Spain, 41013
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08003
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Novartis Investigative Site
Barcelona, Spain, 08041
Novartis Investigative Site
Madrid, Spain, 28034
Novartis Investigative Site
Madrid, Spain, 28041
Novartis Investigative Site
Madrid, Spain, 28050
Novartis Investigative Site
Tainan 704, Taiwan ROC, Taiwan
Novartis Investigative Site
Taipei, Taiwan, 10048
United Kingdom
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Novartis Investigative Site
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Novartis Pharmaceuticals
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00790426    
Other Study ID Numbers: CTKI258A2201
2008-005870-11 ( EudraCT Number )
EudraCT 2008-005870-11
First Posted: November 13, 2008    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: August 2020
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Advanced urothelial cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type