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Phase II Study of TKI258 in Advanced Urothelial Carcinoma

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ClinicalTrials.gov Identifier: NCT00790426
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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

Study Design
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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


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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00790426


Locations
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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
Austria
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
Germany
Novartis Investigative Site
Berlin, Germany, 10098
Novartis Investigative Site
Dresden, Germany, 01307
Novartis Investigative Site
Ulm, Germany, 89081
Italy
Novartis Investigative Site
Roma, RM, Italy, 00152
Spain
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
Taiwan
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
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov 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:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms