Metastatic Breast CancerPhase 2NCT00958971
Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
A Phase 2 study testing TKI258 in people with Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 38 sites in 8 countries.
Trial summary
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- TKI258
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 38 sitesin 8 countries
- Study dates
- Jul 2009to Mar 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female presenting with metastatic breast cancer.
- Tumor must have been tested by FISH/CISH for FGFR1 amplification.
- HER2 and HR status must have been determined.
- Patients must have HER2 negative breast cancer.
- Patients must have a documented disease progression as define by RECIST at baseline.
- Patients with HR+ disease:
Show all 9Show fewer
- Must have received at least one prior endocrine therapy in the metastatic setting.
- Must have received no more than three lines of chemotherapy in the metastatic setting.
- Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
Who cannot join
- Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
- Clinically significant resting bradycardia (< 50 beats per minute).
- LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)< 45%.
- Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
- Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
38 sites in 8 countries.
38 sites in 8 countries
United States18 sites
Comprehensive Blood and Cancer Center Dept CBCC (3)
Bakersfield, California, 93309
Texas Oncology, P.A. Dept. of Texas Oncology
Bedford, Texas, 76022
Tower Cancer Research
Beverly Hills, California, 90211
UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr
Chapel Hill, North Carolina, 27599-7295
Texas Oncology, P.A. Austin
Dallas, Texas, 75246
Texas Oncology, P.A. Presbyterian Hospital
Dallas, Texas, 75246
Texas Oncology, P.A. Texas Oncology - Sammons
Dallas, Texas, 75246
Fairfax Northern Virginia Hematology Oncology Fairfax NVH
Fairfax, Virginia, 22031
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)
Fort Myers, Florida, 33901
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, 89052
UCLA/ University of California Los Angeles Div. of Hematology/Oncology
Los Angeles, California, 90095
Kansas City Cancer Center KCCC (3)
Overland Park, Kansas, 66210
Northwest Cancer Specialists Northwest Office (2)
Portland, Oregon, 97210
Cancer Care Associates Medical Group Dept. of CCA
Redondo Beach, California, 90277
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care
Roanoke, Virginia, 24014
Associates in Oncology/Hematology, P.C.
Rockville, Maryland, 20850
Central Coast Medical Oncology Corporation
Santa Maria, California, 93454
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
Tyler, Texas, 75702
Italy6 sites
Novartis Investigative Site
Candiolo, TO, 10060
Novartis Investigative Site
Cremona, CR, 26100
Novartis Investigative Site
Cuneo, CN, 12100
Novartis Investigative Site
Naples, 80131
Novartis Investigative Site
Negrar, 37024
Novartis Investigative Site
Parma, PR, 43100
France4 sites
Novartis Investigative Site
Lyon, 69373
Novartis Investigative Site
Saint-Herblain Cédex, 44805
Novartis Investigative Site
Toulouse, 31052
Novartis Investigative Site
Villejuif, 94805
Spain3 sites
Novartis Investigative Site
Barcelona, Catalonia, 08035
Novartis Investigative Site
Lleida, Catalonia, 25198
Novartis Investigative Site
Madrid, 28041
United Kingdom3 sites
Novartis Investigative Site
Glasgow, G12 0YN
Novartis Investigative Site
London, SE1 9RT
Novartis Investigative Site
London, SW3 6JJ
Canada2 sites
Novartis Investigative Site
Edmonton, Alberta, T6G 1Z2
Novartis Investigative Site
Montreal, Quebec, H2W 1T8
About this study
Official title: A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
- Conditions
- Metastatic Breast Cancer
- Being tested
- TKI258
- Keywords
- Breast cancer, HER2 negative, FGFR1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TKI258Drug
Also called Dovitinib
All participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles.
| Study group | Role | What they receive |
|---|---|---|
| TKI258 - Positive | Experimental | These are the participants who had a positive T(4;14) status Receives: Drug: TKI258 |
| TKI258 - Negative | Experimental | These are the participants who had a negative T(4;14) status Receives: Drug: TKI258 |
| TKI258 Non-interpretable | Experimental | These are the participants who had a non-interpretable T(4;14) status Receives: Drug: TKI258 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete responses (CR) or partial response (PR) defined according to RECIST
Measured: Every 8 weeks
Secondary outcomes (3)
Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS
Measured: Every 8 weeks
Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events.
Measured: Monthly
Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t)
Measured: Study Day 1, 5 , 26, 52, 78
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast 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
- 43 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
- NCT00958971
- Sponsor's protocol ID
- CTKI258A2202
- Other IDs
- 2008-006430-10, 2008
- Status last verified
- Sep 2020
- First submitted
- 11 Aug 2009
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT00958971
- Acronym / sponsor ID
- CTKI258A2202
- Conditions
- Metastatic Breast Cancer
- Keywords
- Breast cancer, HER2 negative, FGFR1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 14 Aug 2009 (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.
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TKI258 - Positive | Experimental | Drug: TKI258These are the participants who had a positive T(4;14) status |
| TKI258 - Negative | Experimental | Drug: TKI258These are the participants who had a negative T(4;14) status |
| TKI258 Non-interpretable | Experimental | Drug: TKI258These are the participants who had a non-interpretable T(4;14) status |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Female presenting with metastatic breast cancer.
- Tumor must have been tested by FISH/CISH for FGFR1 amplification.
- HER2 and HR status must have been determined.
- Patients must have HER2 negative breast cancer.
- Patients must have a documented disease progression as define by RECIST at baseline.
Key exclusion criteria (8 listed)
- Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
- Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
- Uncontrolled hypertension defined by a SBP > 150mm Hg and/or DBP > 100mm Hg, with or without anti-hypertensive medication.
- 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 |
|---|---|---|
| TKI258Also: DovitinibAll participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles. | Drug | TKI258 - Negative, TKI258 - Positive, TKI258 Non-interpretable |
Primary outcome
Complete responses (CR) or partial response (PR) defined according to RECIST
Time frame: Every 8 weeks
3 secondary outcomes
Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS
Time frame: Every 8 weeks
Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events.
Time frame: Monthly
Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t)
Time frame: Study Day 1, 5 , 26, 52, 78
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.
- Results for CTKI258A2202 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
38 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 Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 38 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 9 inclusion and 8 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 38 sites in United States, Italy, France, Spain, United Kingdom 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?
Complete responses (CR) or partial response (PR) defined according to RECIST (time frame: Every 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.