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Phase II Study of TKI258 in Advanced Urothelial Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00790426
First received: November 10, 2008
Last updated: May 16, 2013
Last verified: May 2013
History of Changes

November 10, 2008
May 16, 2013
March 2010
April 2012   (final data collection date for primary outcome measure)
Overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Progression free survival [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00790426 on ClinicalTrials.gov Archive Site
  • Disease control rate [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • Progression free survival [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
  • overall survival [ Time Frame: 4 Months ] [ Designated as safety issue: No ]
Safety Profile [ Time Frame: Every Visit ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Phase II Study of TKI258 in Advanced Urothelial Carcinoma
A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma

This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Urothelial Cancer
Drug: TKI258
  • Experimental: FGFR3 wild type
    Intervention: Drug: TKI258
  • Experimental: FGFR3 mutant
    Intervention: Drug: TKI258
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2012
April 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Germany,   Italy,   Netherlands,   Spain,   Taiwan,   United Kingdom
 
NCT00790426
CTKI258A2201, 2008-005870-11
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2013

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