NCT00958971已完成2 期
A Multi-center, Open Label Phase II Trial of TKI258 in FGFR1 Amplified and Non-amplified Metastatic or Advanced HER2 Negative Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 19
- 主要终点
- Complete responses (CR) or partial response (PR) defined according to RECIST
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
TKI258 - Positive
Experimental
These are the participants who had a positive T(4;14) status
干预措施: TKI258 (Drug)
TKI258 - Negative
Experimental
These are the participants who had a negative T(4;14) status
干预措施: TKI258 (Drug)
TKI258 Non-interpretable
Experimental
These are the participants who had a non-interpretable T(4;14) status
干预措施: TKI258 (Drug)
结局指标
主要结局
Complete responses (CR) or partial response (PR) defined according to RECIST
时间窗: Every 8 weeks
次要结局
- 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)
研究者
研究点 (19)
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