Phase II Study of TKI258 in Advanced Urothelial Carcinoma

December 11, 2020 updated by: Novartis Pharmaceuticals

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, 1100
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • Novartis Investigative Site
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany, 10098
        • Novartis Investigative Site
      • Dresden, Germany, 01307
        • Novartis Investigative Site
      • Ulm, Germany, 89081
        • Novartis Investigative Site
  • Italy
    • RM
      • Roma, RM, Italy, 00152
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain, 08041
        • Novartis Investigative Site
      • Madrid, Spain, 28041
        • Novartis Investigative Site
      • Madrid, Spain, 28034
        • Novartis Investigative Site
      • Madrid, Spain, 28050
        • Novartis Investigative Site
    • Andalucia
      • Sevilla, Andalucia, Spain, 41013
        • Novartis Investigative Site
    • Catalunya
      • Barcelona, Catalunya, Spain, 08035
        • Novartis Investigative Site
      • Barcelona, Catalunya, Spain, 08003
        • Novartis Investigative Site
  • Taiwan
      • Taipei, Taiwan, 10048
        • Novartis Investigative Site
    • Taiwan ROC
      • Tainan 704, Taiwan ROC, Taiwan
        • Novartis Investigative Site
  • United Kingdom
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Novartis Investigative Site
  • United States
    • California
      • La Jolla, California, United States, 92093-0658
        • University of California San Diego - Moores Cancer Center UCSD
      • Los Angeles, California, United States, 90053
        • USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University Chicago Hospital CTKI258A2201
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute Dana 1230
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Nevada Cancer Institute Nevada Cancer Institute
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • The West Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FGFR3 wild type
Drug: TKI258
Experimental: FGFR3 mutant
Drug: TKI258

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate
Time Frame: 4 months
4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Disease control rate
Time Frame: 4 Months
4 Months
Progression free survival
Time Frame: 4 Months
4 Months
overall survival
Time Frame: 4 Months
4 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

November 10, 2008

First Submitted That Met QC Criteria

November 10, 2008

First Posted (Estimate)

November 13, 2008

Study Record Updates

Last Update Posted (Actual)

December 19, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTKI258A2201
  • 2008-005870-11 (EudraCT Number)
  • EudraCT 2008-005870-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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