NCT04060511已完成1 期
A Phase 1, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-10342 in Patients With Advanced Solid Tumor
Jiangsu Hansoh Pharmaceutical Co., Ltd.5 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2019年6月19日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 5
- 主要终点
- Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342.
研究概览
简要总结
HS-10342 is a small molecular, oral potent, selective CDK4/6 inhibitor. The purpose of this study is to investigate the safety/tolerability and the pharmacokinetic profile of HS-10342 in Chinese advanced solid tumor patients. Preliminary efficacy will be also investigated in this study.
详细描述
This is a phase 1, multicenter study to evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-10342 in patients with advanced solid tumor by using a "3+3" dose escalation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following inclusion criteria to be eligible for participation in this study:
- •Pathologically confirmed solid tumor and failed from all standard treatment.
- •At least one extracranial measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.
- •Eastern Cooperative Oncology Group (ECOG) performance status: 0-
- •Life expectancy ≥ 3 months.
- •Adequate function of major organs meets the following requirements:
- •Neutrophils ≥ 1.5×10^9/L
- •Platelets ≥ 90×10^9/L
- •Hemoglobin ≥ 90g/L
- •Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
- •ALT and AST ≤ 2.5 × ULN
- •Cr ≤ 1.5 × ULN
- •Left ventricular ejection fraction (LVEF) ≥ 40%
- •Good compliance of patient by physician's judgement.
- •. Signed and dated informed consent.
排除标准
- •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study:
- •Previously received therapy of anti-tumor agent targeting at CDK4/
- •Less than 3 weeks from the last cell-toxicity chemotherapy, less than 6 weeks from last mitomycin or nitrosamine therapy
- •Less than 3 weeks from any other anti-tumor therapy (including targets therapy, immunotherapy or other approved therapy)
- •Less than 4 weeks from large area radiotherapy.
- •Less than 7 days from any CYP3A4 strong inhibitor, strong inducer or a narrow window of medicine or food for CYP3A4 sensitive substrate.
- •Having joined in other clinical trials within 4 weeks.
- •Brain metastasis (well-controlled/well-treated brain metastasis by physician's judgement is allowed).
- •Existing abnormal CTCAE≥grade 2 resulted from previous treatment(except grade 2 alopecia).
- •Uncontrollable pleural effusion or ascites.
- •Inability to swallow, intestinal obstruction or other factors affecting the administration and absorption of the drug.
- •History of serious allergy events or known being allergy constitution, or have a history of allergies to the drug components of this regimen.
- •Patients with active infection.
- •History of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency disease, history of organ transplantation.
- •History of uncontrollable cardiac dysfunction, include(1)angina (2)clinical significant arrythmia or require drug intervention (3)myocardial infarction Less than 6 moths (4) other cardiac dysfunction (judged by the physician), such as any degree of heart block or QTc prolongation, QT interval corrected by Fridericia method(QTcF) >450 ms(men) or >470 ms(women); (5)any cardiac or nephric abnormal ≥ grade 2 found in screening.
- •Males and females of reproductive potential who are unwilling to use an "effective", protocol specified method(s) of contraception during the study.
- •Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
- •History of neuropathy or dysphrenia, including epilepsy and dementia
- •Determined by the physician, any coexisting disease might lead to life threatening complications or avoid the patients from accomplishing the treatment.
研究组 & 干预措施
HS-10342
Experimental
Each subject will receive a single dose(C0) of HS-10342 and then repeat doses(C1, C2...) for 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
干预措施: HS-10342 (Drug)
结局指标
主要结局
Dose-Limiting Toxicity and Maximum Tolerated Dose of HS-10342.
时间窗: 5 weeks
The maximum-tolerated dose (MTD) will be defined as the maximum dose level at which no more than one out of three subjects experience a dose-limiting toxicity (DLT) within the 5 week after the first dose.
次要结局
未报告次要终点
研究者
研究点 (5)
Loading locations...
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