Phase II Study of TKI258 in Advanced Urothelial Carcinoma

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

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

Condition Intervention Phase
Urothelial Cancer
Drug: TKI258
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 44
Study Start Date: March 2010
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FGFR3 wild type Drug: TKI258
Experimental: FGFR3 mutant Drug: TKI258


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Please refer to this study by its identifier: NCT00790426

  Show 50 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals ) Identifier: NCT00790426     History of Changes
Other Study ID Numbers: CTKI258A2201, 2008-005870-11
Study First Received: November 10, 2008
Last Updated: May 16, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Canada: Health Canada
Germany: BfArM
Italy: The Italian Medicines Agency
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Spain: Spanish Agency of Medicines
Taiwan: Center of Drug Evaluation

Keywords provided by Novartis:
Advanced urothelial cancer

Additional relevant MeSH terms:
Carcinoma, Transitional Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms processed this record on April 17, 2014