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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006430-10 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TKI258 - Positive | Experimental | These are the participants who had a positive T(4;14) status |
|
| TKI258 - Negative | Experimental | These are the participants who had a negative T(4;14) status |
|
| TKI258 Non-interpretable | Experimental | These are the participants who had a non-interpretable T(4;14) status |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TKI258 | Drug | All participants received a singly daily oral dose of 500 mg dovitinib on a 5 days on/2 days off schedule in 28 cycles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete responses (CR) or partial response (PR) defined according to RECIST | Every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS | Every 8 weeks | |
| Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. | Monthly |
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Inclusion Criteria:
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:
Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
Exclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Blood and Cancer Center Dept CBCC (3) | Bakersfield | California | 93309 | United States | ||
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| Label | URL |
|---|---|
| Results for CTKI258A2202 from the Novartis Clinical Trials website | View source |
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|
| Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) | Study Day 1, 5 , 26, 52, 78 |
| Tower Cancer Research |
| Beverly Hills |
| California |
| 90211 |
| United States |
| UCLA/ University of California Los Angeles Div. of Hematology/Oncology | Los Angeles | California | 90095 | United States |
| Cancer Care Associates Medical Group Dept. of CCA | Redondo Beach | California | 90277 | United States |
| Central Coast Medical Oncology Corporation | Santa Maria | California | 93454 | United States |
| Florida Cancer Specialists Dept.of FloridaCancerSpec. (2) | Fort Myers | Florida | 33901 | United States |
| Kansas City Cancer Center KCCC (3) | Overland Park | Kansas | 66210 | United States |
| Associates in Oncology/Hematology, P.C. | Rockville | Maryland | 20850 | United States |
| Comprehensive Cancer Centers of Nevada | Henderson | Nevada | 89052 | United States |
| UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr | Chapel Hill | North Carolina | 27599-7295 | United States |
| Northwest Cancer Specialists Northwest Office (2) | Portland | Oregon | 97210 | United States |
| Texas Oncology, P.A. Dept. of Texas Oncology | Bedford | Texas | 76022 | United States |
| Texas Oncology, P.A. Austin | Dallas | Texas | 75246 | United States |
| Texas Oncology, P.A. Presbyterian Hospital | Dallas | Texas | 75246 | United States |
| Texas Oncology, P.A. Texas Oncology - Sammons | Dallas | Texas | 75246 | United States |
| Tyler Cancer Center Dept.ofTylerCancerCtr. (2) | Tyler | Texas | 75702 | United States |
| Fairfax Northern Virginia Hematology Oncology Fairfax NVH | Fairfax | Virginia | 22031 | United States |
| Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care | Roanoke | Virginia | 24014 | United States |
| Novartis Investigative Site | Edmonton | Alberta | T6G 1Z2 | Canada |
| Novartis Investigative Site | Montreal | Quebec | H2W 1T8 | Canada |
| Novartis Investigative Site | Helsinki | FIN-00029 | Finland |
| Novartis Investigative Site | Lyon | 69373 | France |
| Novartis Investigative Site | Saint-Herblain Cédex | 44805 | France |
| Novartis Investigative Site | Toulouse | 31052 | France |
| Novartis Investigative Site | Villejuif | 94805 | France |
| Novartis Investigative Site | Cuneo | CN | 12100 | Italy |
| Novartis Investigative Site | Cremona | CR | 26100 | Italy |
| Novartis Investigative Site | Parma | PR | 43100 | Italy |
| Novartis Investigative Site | Candiolo | TO | 10060 | Italy |
| Novartis Investigative Site | Naples | 80131 | Italy |
| Novartis Investigative Site | Negrar | 37024 | Italy |
| Novartis Investigative Site | Barcelona | Catalonia | 08035 | Spain |
| Novartis Investigative Site | Lleida | Catalonia | 25198 | Spain |
| Novartis Investigative Site | Madrid | 28041 | Spain |
| Novartis Investigative Site | Taipei | 10048 | Taiwan |
| Novartis Investigative Site | Glasgow | G12 0YN | United Kingdom |
| Novartis Investigative Site | London | SE1 9RT | United Kingdom |
| Novartis Investigative Site | London | SW3 6JJ | United Kingdom |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C500007 | 4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one |
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