Urothelial CancerPhase 2NCT00790426
Phase II Study of TKI258 in Advanced Urothelial Carcinoma
A Phase 2 study testing TKI258 in people with Urothelial Cancer, run by Novartis Pharmaceuticals at 26 sites in 8 countries.
Trial summary
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Cancer
- What is being tested?
- TKI258
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 26 sitesin 8 countries
- Study dates
- Mar 2010to Apr 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
26 sites in 8 countries.
26 sites in 8 countries
United States8 sites
Dana Farber Cancer Institute Dana 1230
Boston, Massachusetts, 02215
University Chicago Hospital CTKI258A2201
Chicago, Illinois, 60637
Duke University Medical Center Dept.ofDukeUniversityMedCtr(2)
Durham, North Carolina, 27710
University of California San Diego - Moores Cancer Center UCSD
La Jolla, California, 92093-0658
Nevada Cancer Institute Nevada Cancer Institute
Las Vegas, Nevada, 89135
USC/Kenneth Norris Comprehensive Cancer Center Regulatory Contact 3
Los Angeles, California, 90053
The West Clinic
Memphis, Tennessee, 38120
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering (2)
New York, New York, 10065
Spain7 sites
Novartis Investigative Site
Barcelona, Catalonia, 08003
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Barcelona, 08041
Novartis Investigative Site
Madrid, 28034
Novartis Investigative Site
Madrid, 28041
Novartis Investigative Site
Madrid, 28050
Novartis Investigative Site
Seville, Andalusia, 41013
Germany3 sites
Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Dresden, 01307
Novartis Investigative Site
Ulm, 89081
Canada2 sites
Novartis Investigative Site
Toronto, Ontario, M5G 2M9
Novartis Investigative Site
Victoria, British Columbia, V8R 6V5
Taiwan2 sites
Novartis Investigative Site
Tainan, Taiwan ROC
Novartis Investigative Site
Taipei, 10048
United Kingdom2 sites
Novartis Investigative Site
Leeds, West Yorkshire, LS9 7TF
Novartis Investigative Site
Southampton, SO16 6YD
About this study
Official title: 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
- Conditions
- Urothelial Cancer
- Being tested
- TKI258
- Keywords
- Advanced urothelial cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI258Drug
| Study group | Role | What they receive |
|---|---|---|
| FGFR3 wild type | Experimental | Not described Receives: Drug: TKI258 |
| FGFR3 mutant | Experimental | Not described Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: 4 months
Secondary outcomes (3)
Disease control rate
Measured: 4 Months
Progression free survival
Measured: 4 Months
overall survival
Measured: 4 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startMar 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Urothelial CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790426
- Sponsor's protocol ID
- CTKI258A2201
- Other IDs
- 2008-005870-11, EudraCT 2008-005870-11, 2008
- Status last verified
- Aug 2020
- First submitted
- 10 Nov 2008
- Last updated
- 19 Dec 2020
- Results posted
- No
Publications
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.
PubMed 25457633
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi-center, Non-randomized, Open Label Study of TKI258 in FGFR3 Mutated and FGFR3 Wild Type Advanced Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT00790426
- Acronym / sponsor ID
- CTKI258A2201
- Conditions
- Urothelial Cancer
- Keywords
- Advanced urothelial cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 13 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy of TKI258 in patients with advanced urothelial cancer
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGFR3 wild type | Experimental | Drug: TKI258 |
| FGFR3 mutant | Experimental | Drug: TKI258 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TKI258 | Drug | FGFR3 mutant, FGFR3 wild type |
Primary outcome
Overall response rate
Time frame: 4 months
3 secondary outcomes
Disease control rate
Time frame: 4 Months
Progression free survival
Time frame: 4 Months
overall survival
Time frame: 4 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Derived from this study: PubMed 25457633Milowsky 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 for CTKI258A2201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
26 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TKI258 in people with Urothelial Cancer, run by Novartis Pharmaceuticals at 26 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, Spain, Germany, Canada, Taiwan and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00790426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2020.