NCT01937689已完成1 期
A Phase I Study of Pyrotinib in Patients With HER2 Positive Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
研究概览
简要总结
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is designed to evaluate the safety and tolerability of Pyrotinib in patients with HER2 positive advanced breast cancer:
- To evaluate the safety and tolerability of pyrotinib, and the maximum tolerated dose (MTD)
- To determine the dose-limiting toxicity (DLT)
- To determine the pharmacokinetic profile of Pyrotinib and its metabolites
- To assess preliminary antitumor activity
- To determine preliminary regimen dose for phase II study
- To explore the relationship between biomarkers and the toxicity/efficacy of Pyrotinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥18 and ≤70 years.
- •ECOG performance status of 0 to
- •Life expectancy of more than 12 weeks.
- •At least one measurable lesion exists.(RECIST 1.1)
- •Histologically or cytologic confirmed HER2 positive advanced breast cancer which failed prior therapies.
- •Required laboratory values including following parameters:
- •ANC: ≥ 1.5 x 109/L
- •Platelet count: ≥ 100 x 109/L
- •Hemoglobin: ≥ 9.0 g/dL
- •Total bilirubin: ≤ 1.5 x upper limit of normal, ULN
- •ALT and AST: ≤ 1.5 x ULN
- •BUN and creatine clearance rate: ≥ 50 mL/min
- •LVEF: ≥ 50%
- •QTcF: < 470 ms
- •Signed informed consent.
排除标准
- •Subjects with third space fluid that can not be controled by drainage or other methods.
- •Steroid treatment for more than 50 days, or in need of long-term use of steroids.
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption.
- •Less than 4 weeks from the last radiotherapy,chemotherapy，surgery，hermone treatment,target therapy, or less than 6 weeks from the nitrosoureas or mitomycin chemotherapy.
- •Subjects with uncontrolled hypokalemia and hypomagnesemia before study entry.
- •Subjects who can not interrupt the using of the drugs that may cause QT prolongation during study.
- •Subjects with intracranial lesions.
- •Treated or treating with HER2 tyrosine kinase inhibitors (TKIs) before study entry.
- •Receiving any other antitumor therapy.
- •Less than 4 weeks from the last clinical trial.
- •Known history of hypersensitivity to pyrotinib or any of it components.
- •Ongoing infection (determined by investigator).
- •History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation.
- •Subjects had any heart disease, including: (1) angina; (2) requiring medication or clinically significant arrhythmia; (3) myocardial infarction; (4) heart failure; (5) Any heart diseases judged by investigator as unsuitable to participate in the trial.
- •Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test.
- •Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period.
- •Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study. Examples include, but are not limited to,hypertension, severe diabetes, or thyroid disease.
- •Alcoholism, smoking (daily ≥ 5 roots) and other bad habits.
- •Known history of neurological or psychiatric disease, including epilepsy or dementia.
研究组 & 干预措施
Pyrotinib
Experimental
Each subject will receive a single dose of pyrotinib on day 1, followed by 4-day observation period, and then subject will receive pyrotinib once daily for 28 days during cycle 1.Each cycle will consists of 28 days.
干预措施: Pyrotinib (Drug)
结局指标
主要结局
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one subject out of three experiences has a dose-limiting toxicity (DLT) upon completing one treatment cycle.
时间窗: 4 weeks
次要结局
- Objective response rate (ORR).(8 weeks)
- Pyrotinib pharmacokinetic parameter: Cmax.(4 weeks)
- Pyrotinib pharmacokinetic parameter: Tmax.(4 weeks)
- Pyrotinib pharmacokinetic parameter: t1/2.(4 weeks)
- Pyrotinib pharmacokinetic parameter: AUC.(4 weeks)
- Number of participants with adverse events.(8 weeks)
研究者
研究点 (1)
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