Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer
This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
First received: August 11, 2009
Last updated: February 9, 2013
Last verified: February 2013
The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 4 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.
Metastatic Breast Cancer
||Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer
Primary Outcome Measures:
- Complete responses (CR) or partial response (PR) defined according to RECIST [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Benefit (CR, PR and SD ≥ 24 weeks after start of study treatment), PFS [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ]
- Safety and tolerability of TKI258 treatment assessed by frequency and severity of Adverse Events. [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
- Pharmacokinetic: plasma concentrations and PK parameters (e.g. Cmax, Tmax, AUC0-t) [ Time Frame: Study Day 1, 5 , 26, 52, 78 ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||March 2011 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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:
- 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.
- 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00958971
No publications provided
||Novartis ( Novartis Pharmaceuticals )
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 11, 2009
||February 9, 2013
||United States: Food and Drug Administration
Canada: Health Canada
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Italy: Ministry of Health
Spain: Ministry of Health
Taiwan: Department of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by Novartis:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 03, 2013
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