Metastatic Breast Cancer Clinical Trial
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
| Verified date | September 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 43 |
| Est. completion date | March 2011 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 1. Female presenting with metastatic breast cancer. 2. Tumor must have been tested by FISH/CISH for FGFR1 amplification. 3. HER2 and HR status must have been determined. 4. Patients must have HER2 negative breast cancer. 5. Patients must have a documented disease progression as define by RECIST at baseline. 6. Patients with HR+ disease: - 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. 7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting. Exclusion Criteria: 1. 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. 2. 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%. 3. 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). 4. 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Novartis Investigative Site | Edmonton | Alberta |
| Canada | Novartis Investigative Site | Montreal | Quebec |
| Finland | Novartis Investigative Site | Helsinki | |
| France | Novartis Investigative Site | Lyon Cedex | |
| France | Novartis Investigative Site | Saint-Herblain Cédex | |
| France | Novartis Investigative Site | Toulouse Cedex 3 | |
| France | Novartis Investigative Site | Villejuif Cedex | |
| Italy | Novartis Investigative Site | Candiolo | TO |
| Italy | Novartis Investigative Site | Cremona | CR |
| Italy | Novartis Investigative Site | Cuneo | CN |
| Italy | Novartis Investigative Site | Napoli | |
| Italy | Novartis Investigative Site | Negrar | |
| Italy | Novartis Investigative Site | Parma | PR |
| Spain | Novartis Investigative Site | Barcelona | Cataluña |
| Spain | Novartis Investigative Site | Lleida | Cataluña |
| Spain | Novartis Investigative Site | Madrid | |
| Taiwan | Novartis Investigative Site | Taipei | |
| United Kingdom | Novartis Investigative Site | Glasgow | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | London | |
| United States | Comprehensive Blood and Cancer Center Dept CBCC (3) | Bakersfield | California |
| United States | Texas Oncology, P.A. Dept. of Texas Oncology | Bedford | Texas |
| United States | Tower Cancer Research | Beverly Hills | California |
| United States | UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr | Chapel Hill | North Carolina |
| United States | Texas Oncology, P.A. Austin | Dallas | Texas |
| United States | Texas Oncology, P.A. Presbyterian Hospital | Dallas | Texas |
| United States | Texas Oncology, P.A. Texas Oncology - Sammons | Dallas | Texas |
| United States | Fairfax Northern Virginia Hematology Oncology Fairfax NVH | Fairfax | Virginia |
| United States | Florida Cancer Specialists Dept.of FloridaCancerSpec. (2) | Fort Myers | Florida |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | UCLA/ University of California Los Angeles Div. of Hematology/Oncology | Los Angeles | California |
| United States | Kansas City Cancer Center KCCC (3) | Overland Park | Kansas |
| United States | Northwest Cancer Specialists Northwest Office (2) | Portland | Oregon |
| United States | Cancer Care Associates Medical Group Dept. of CCA | Redondo Beach | California |
| United States | Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care | Roanoke | Virginia |
| United States | Associates in Oncology/Hematology, P.C. | Rockville | Maryland |
| United States | Central Coast Medical Oncology Corporation | Santa Maria | California |
| United States | Tyler Cancer Center Dept.ofTylerCancerCtr. (2) | Tyler | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Canada, Finland, France, Italy, Spain, Taiwan, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete responses (CR) or partial response (PR) defined according to RECIST | Every 8 weeks | ||
| Secondary | Clinical Benefit (CR, PR and SD = 24 weeks after start of study treatment), PFS | Every 8 weeks | ||
| Secondary | Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. | Monthly | ||
| Secondary | Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) | Study Day 1, 5 , 26, 52, 78 |
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