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Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Primary Purpose

Urothelial Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
TKI258
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urothelial Cancer focused on measuring Advanced urothelial cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California San Diego - Moores Cancer Center UCSD
  • USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
  • University Chicago Hospital CTKI258A2201
  • Dana Farber Cancer Institute Dana 1230
  • Nevada Cancer Institute Nevada Cancer Institute
  • Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
  • Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
  • The West Clinic
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

FGFR3 wild type

FGFR3 mutant

Arm Description

Outcomes

Primary Outcome Measures

Overall response rate

Secondary Outcome Measures

Disease control rate
Progression free survival
overall survival

Full Information

First Posted
November 10, 2008
Last Updated
December 11, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00790426
Brief Title
Phase II Study of TKI258 in Advanced Urothelial Carcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Cancer
Keywords
Advanced urothelial cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
FGFR3 wild type
Arm Type
Experimental
Arm Title
FGFR3 mutant
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
TKI258
Primary Outcome Measure Information:
Title
Overall response rate
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Disease control rate
Time Frame
4 Months
Title
Progression free survival
Time Frame
4 Months
Title
overall survival
Time Frame
4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of California San Diego - Moores Cancer Center UCSD
City
La Jolla
State/Province
California
ZIP/Postal Code
92093-0658
Country
United States
Facility Name
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
City
Los Angeles
State/Province
California
ZIP/Postal Code
90053
Country
United States
Facility Name
University Chicago Hospital CTKI258A2201
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana Farber Cancer Institute Dana 1230
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Nevada Cancer Institute Nevada Cancer Institute
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The West Clinic
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1100
Country
Austria
Facility Name
Novartis Investigative Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00152
Country
Italy
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08035
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Novartis Investigative Site
City
Tainan 704
State/Province
Taiwan ROC
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10048
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Leeds
State/Province
West Yorkshire
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25457633
Citation
Milowsky MI, Dittrich C, Duran I, Jagdev S, Millard FE, Sweeney CJ, Bajorin D, Cerbone L, Quinn DI, Stadler WM, Rosenberg JE, Lochheed M, Sen P, Squires M, Shi M, Sternberg CN. Phase 2 trial of dovitinib in patients with progressive FGFR3-mutated or FGFR3 wild-type advanced urothelial carcinoma. Eur J Cancer. 2014 Dec;50(18):3145-52. doi: 10.1016/j.ejca.2014.10.013. Epub 2014 Oct 30.
Results Reference
derived
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=8383
Description
Results for CTKI258A2201 from the Novartis Clinical Trials website

Learn more about this trial

Phase II Study of TKI258 in Advanced Urothelial Carcinoma

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