Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_2

Timeline

Completed

Started Mar 2010

Geographic Reach

8 countries

26 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

November 10, 2008

Completed

3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed

1.3 years until next milestone

Study Start

First participant enrolled

March 1, 2010

Completed

2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed

Last Updated

December 19, 2020

Status Verified

August 1, 2020

Enrollment Period

2.1 years

First QC Date

November 10, 2008

Last Update Submit

December 11, 2020

Conditions

Urothelial Cancer

Keywords

Advanced urothelial cancer

Outcome Measures

Primary Outcomes (1)

Overall response rate
4 months

Secondary Outcomes (3)

Disease control rate
4 Months
Progression free survival
4 Months
overall survival
4 Months

Study Arms (2)

FGFR3 wild type

EXPERIMENTAL

Drug: TKI258

FGFR3 mutant

EXPERIMENTAL

Drug: TKI258

Interventions

TKI258DRUG

FGFR3 mutantFGFR3 wild type

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novartis Pharmaceuticalslead

Study Sites (26)

University of California San Diego - Moores Cancer Center UCSD

La Jolla, California, 92093-0658, United States

Location

USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3

Los Angeles, California, 90053, United States

Location

University Chicago Hospital CTKI258A2201

Chicago, Illinois, 60637, United States

Location

Dana Farber Cancer Institute Dana 1230

Boston, Massachusetts, 02215, United States

Location

Nevada Cancer Institute Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Location

Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)

New York, New York, 10065, United States

Location

Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)

Durham, North Carolina, 27710, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

Novartis Investigative Site

Vienna, 1100, Austria

Location

Novartis Investigative Site

Victoria, British Columbia, V8R 6V5, Canada

Location

Novartis Investigative Site

Toronto, Ontario, M5G 2M9, Canada

Location

Novartis Investigative Site

Berlin, 10098, Germany

Location

Novartis Investigative Site

Dresden, 01307, Germany

Location

Novartis Investigative Site

Ulm, 89081, Germany

Location

Novartis Investigative Site

Roma, RM, 00152, Italy

Location

Novartis Investigative Site

Seville, Andalusia, 41013, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08003, Spain

Location

Novartis Investigative Site

Barcelona, Catalonia, 08035, Spain

Location

Novartis Investigative Site

Barcelona, 08041, Spain

Location

Novartis Investigative Site

Madrid, 28034, Spain

Location

Novartis Investigative Site

Madrid, 28041, Spain

Location

Novartis Investigative Site

Madrid, 28050, Spain

Location

Novartis Investigative Site

Tainan, Taiwan ROC, Taiwan

Location

Novartis Investigative Site

Taipei, 10048, Taiwan

Location

Novartis Investigative Site

Leeds, West Yorkshire, LS9 7TF, United Kingdom

Location

Novartis Investigative Site

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (1)

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.
PMID: 25457633DERIVED

MeSH Terms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Study Officials

Novartis Pharmaceuticals
Novartis Pharmaceuticals
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 10, 2008

First Posted

November 13, 2008

Study Start

March 1, 2010

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

December 19, 2020

Record last verified: 2020-08

Locations

GB(2)US(8)CA(2)AU(1)IT(1)DE(3)ES(7)TW(2)

Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

FGFR3 wild type

FGFR3 mutant

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Study Arms (2)

FGFR3 wild type

FGFR3 mutant

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (26)

Related Publications (1)

Related Links

MeSH Terms

Interventions

Study Officials

Study Design

Study Record Dates

Locations