A Phase II Study of the Ningetinib in Advanced NSCLC With MET Exon 14 Skipping Mutations
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 80
- 主要终点
- Recommended Extended Dose
研究概览
简要总结
This is a phase II, Single-arm,Open-label Study evaluating the safety and efficacy of CT053PTSA in Advanced Solid Tumors With MET Exon 14 Skipping Mutations
详细描述
This study is being carried out in two parts, part 1 and part 2. Part 1:Observation phase of dose tolerance: Objective To observe the tolerability and safety of 60 mg CT053PTSA in advanced NSCLC patients with Metex14 skipping mutation, and to determine the recommended dose (RED) in the dose expansion phase。 Part 2: This is the expansion part and will continue to evaluate the safety and efficacy of CT053PTSA at the dose of RED in advanced NSCLC patients with Metex14 skipping mutation.
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
- •Age:18-75 years, male or female.
- •Histologically or cytologically confirmed IIIB-IV- Advanced NSCLC
- •There was a Metex 14 skipping mutation in plasma and / or tissue
- •Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 ~2
- •Life expectancy of greater than 12 weeks.
- •Evaluable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
- •Adequate organ function.
- •Contraception, fertility and not lactating female subjects: screening blood pregnancy test must be negative
- •Voluntarily join the study and sign informed consent ad has good compliance.
排除标准
- •EGFR or ALK or ROS1 gene mutation was positive
- •Anthracycline, nitrosourea, and mitomycin within 6 weeks; traditional Chinese medicine for anti-tumor within 2 weeks;other anti-tumor therapies within 4 weeks, Previously or currently participating in other clinical trials within 4 week, Prior therapies with c-MET targeted drugs; Had received vaccine within 4 weeks prior to study treatment or had a plan to receive vaccine during the trial.
- •Not recovered from adverse events due to a previously administered agent.
- •Symptomatic, untreated or unstable central nervous system metastases/ spinal cord compression, cancerous meningitis, or meningitis.
- •Patients with other malignant tumors except NSCLC within 5 years before the first use of drugs do not include those with negligible risk of metastasis or death (such as expected 5-year OS > 90%) and expected to be cured after treatment, or any other tumors that have been cured (no evidence of recurrence within 5 years)
- •There are prescribed cardiovascular and cerebrovascular risk factors
- •Patients with evidence of bleeding tendency, or melena or hematemesis within 2 months; or visceral bleeding that may occur considered by investigator
- •History of thyroid dysfunction, and the thyroid function cannot be maintained at the normal range with drugs.
- •There are uncontrollable and active infections
- •Uncontrollable massive pleural / ascites or pericardial effusion
- •Clinically significant gastrointestinal abnormalities may affect the drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.), or total gastrectomy subjects;
- •a history of psychotropic drug abuse and can not quit or have mental disorders
- •Any other reason the investigator considers the patient is not suitable to participate in the study
研究组 & 干预措施
CT053PTSA
60 mg/d, starting on the first day
干预措施: CT053PTSA (Drug)
结局指标
主要结局
Recommended Extended Dose
时间窗: Cycle 1Day 1 to Cycle 1 Day 28±3
Recommended dose for expansion phase
Objective response rate
时间窗: up to 4 years
Objective response rate (ORR) is defined as the percentage of the participants in the analysis population who have a confirmed complete response (CR) or partial response (PR) based on RECIST 1.1 by investigators
次要结局
- Disease Control Rate(up to 4 years)
- Overall survival(up to 4 years)
- Duration of response(up to 4 years)
- Progression-free survival(up to 4 years)
- Adverse events related to CT053(up to 4 years)