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
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790426

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

No publications provided

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

ClinicalTrials.gov processed this record on July 23, 2014