Effect of High-fat Meal on the Pharmacokinetics of TQ-B3139 Capsules
A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor
研究概览
研究类型
注册 (预期的)
阶段
- 阶段1
联系人和位置
学习地点
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Hunan
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Changsha、Hunan、中国、410000
- 招聘中
- Hunan Cancer Hospital
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首席研究员：
- Nong Yang, Doctor
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接触：
- Nong Yang, Doctor
- 电话号码：0731-89762320
- 邮箱：yangnongpi@163.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 1.
2. Life expectancy ≥12 weeks. 3. Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
4. Adequate organ system function. 5.Female patients of childbearing age should agree to use contraceptive measures during the study period and for at least 6 months after study is stopped; male patients should agree to use contraception during the study period and for at least 6 months after study is stopped.
6.Understood and signed an informed consent form.
Exclusion Criteria:
1. Has other malignancies within 3 years. 2. Has multiple factors affecting oral medication. 3. The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
4. Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
5. Has long-term unhealed wounds or fractures. 6. Has a history of psychotropic drug abuse or have a mental disorder. 7. Has any severe and/or uncontrolled disease. 8. Has received surgery, chemotherapy, radiotherapy or other anticancer therapies 4 weeks or 5 half-life of drug elimination (whichever comes first) before the first dose.
9. Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present. 11. Has receiving Chinese patent medicines with anti-tumor indications in the drug instructions that NMPA approved within 2 weeks before the start of the study treatment.
12. Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
13. Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.
14. In lactation period or plan to breastfeed during the study period. 15.According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Cohort 1
TQ-B3139 capsules administered single dose of 600 mg under fasted conditions in day 1 followed by single dose of 600 mg with a high-fat meal in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily.
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TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
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实验性的：Cohort 2
TQ-B3139 capsules administered single dose of 600 mg with a high-fat meal in day 1 followed by single dose of 600 mg under fasted conditions in day 5, then TQ-B3139 capsules administered 600mg orally, twice daily.
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TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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AUC0-t
大体时间：0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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AUC0-∞
大体时间：0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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Cmax
大体时间：0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Tmax
大体时间：0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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To characterize the pharmacokinetics of TQ-B3139 by assessment of time to reach maximum plasma concentration.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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t1/2
大体时间：0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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t1/2 is time it takes for the blood concentration of TQ-B3139 or metabolite(s) to drop by half.
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0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
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Objective Response Rate (ORR)
大体时间：up to 24 months
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Percentage of participants achieving complete response (CR) and partial response (PR).
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up to 24 months
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Progression-free survival (PFS)
大体时间：up to 24 months
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PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
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up to 24 months
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Disease control rate (DCR)
大体时间：up to 24 months
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Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
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up to 24 months
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Duration of response (DOR)
大体时间：up to 24 months
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DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
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up to 24 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- TQ-B3139-I-02
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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