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Phase II Study of TKI258 in Advanced Urothelial Carcinoma

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00790426
Collaborator
(none)
44
Enrollment
26
Locations
2
Arms
25
Duration (Months)
1.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (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
Study Start Date :
Mar 1, 2010
Actual Primary Completion Date :
Apr 1, 2012
Actual Study Completion Date :
Apr 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: FGFR3 wild type

Drug: TKI258
Experimental: FGFR3 mutant

Drug: TKI258

Outcome Measures

Primary Outcome Measures

  1. Overall response rate [4 months]

Secondary Outcome Measures

  1. Disease control rate [4 Months]

  2. Progression free survival [4 Months]

  3. overall survival [4 Months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Locations

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

Sponsors and Collaborators

  • Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00790426
Other Study ID Numbers:
  • CTKI258A2201
  • 2008-005870-11
  • EudraCT 2008-005870-11
First Posted:
Nov 13, 2008
Last Update Posted:
Dec 19, 2020
Last Verified:
Aug 1, 2020
Keywords provided by Novartis Pharmaceuticals
Advanced urothelial cancer
Additional relevant MeSH terms:
Carcinoma, Transitional Cell

Study Results

No Results Posted as of Dec 19, 2020