Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
- Registration Number
- NCT00958971
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 43
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Female presenting with metastatic breast cancer.
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Tumor must have been tested by FISH/CISH for FGFR1 amplification.
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HER2 and HR status must have been determined.
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Patients must have HER2 negative breast cancer.
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Patients must have a documented disease progression as define by RECIST at baseline.
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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.
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Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.
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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.
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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%.
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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).
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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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TKI258 Non-interpretable TKI258 These are the participants who had a non-interpretable T(4;14) status TKI258 - Negative TKI258 These are the participants who had a negative T(4;14) status TKI258 - Positive TKI258 These are the participants who had a positive T(4;14) status
- Primary Outcome Measures
Name Time Method Complete responses (CR) or partial response (PR) defined according to RECIST Every 8 weeks
- Secondary Outcome Measures
Name Time Method Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. Monthly Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS Every 8 weeks Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) Study Day 1, 5 , 26, 52, 78
Trial Locations
- Locations (19)
Texas Oncology, P.A. Presbyterian Hospital
🇺🇸Dallas, Texas, United States
Comprehensive Blood and Cancer Center Dept CBCC (3)
🇺🇸Bakersfield, California, United States
Tower Cancer Research
🇺🇸Beverly Hills, California, United States
UCLA/ University of California Los Angeles Div. of Hematology/Oncology
🇺🇸Los Angeles, California, United States
Central Coast Medical Oncology Corporation
🇺🇸Santa Maria, California, United States
Texas Oncology, P.A. Texas Oncology - Sammons
🇺🇸Dallas, Texas, United States
Texas Oncology, P.A. Dept. of Texas Oncology
🇺🇸Bedford, Texas, United States
Tyler Cancer Center Dept.ofTylerCancerCtr. (2)
🇺🇸Tyler, Texas, United States
Fairfax Northern Virginia Hematology Oncology Fairfax NVH
🇺🇸Fairfax, Virginia, United States
Associates in Oncology/Hematology, P.C.
🇺🇸Rockville, Maryland, United States
Kansas City Cancer Center KCCC (3)
🇺🇸Overland Park, Kansas, United States
UNC/ Lineberger Comprehensive Cancer Center Dept. of Linberger Cancer Ctr
🇺🇸Chapel Hill, North Carolina, United States
Cancer Care Associates Medical Group Dept. of CCA
🇺🇸Redondo Beach, California, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
Florida Cancer Specialists Dept.of FloridaCancerSpec. (2)
🇺🇸Fort Myers, Florida, United States
Novartis Investigative Site
🇬🇧London, United Kingdom
Northwest Cancer Specialists Northwest Office (2)
🇺🇸Portland, Oregon, United States
Texas Oncology, P.A. Austin
🇺🇸Dallas, Texas, United States
Blue Ridge Research Center at Roanoke Neurological Center Blue Ridge Cancer Care
🇺🇸Roanoke, Virginia, United States