A Study of the Effect of High-fat Meal on the Pharmacokinetics of Oral TQ-B3139 Capsules in Patients With Solid Tumor
试验速览
- 阶段
- 1 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- AUC0-t
研究概览
简要总结
This is a study to evaluate the effect of high-fat meal on the pharmacokinetics of TQ-B3139 capsules in patients with solid tumor
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to
- •Life expectancy ≥12 weeks.
- •Patients with confirmed gene mutations, including ALK fusion, ROS1 fusion, MET mutation or amplification.
- •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.
排除标准
- •Has other malignancies within 3 years.
- •Has multiple factors affecting oral medication.
- •The toxicity of previous antitumor treatment is not recovered to ≤ grade 1(CTCAE 5.0) .
- •Has received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before the first dose.
- •Has long-term unhealed wounds or fractures.
- •Has a history of psychotropic drug abuse or have a mental disorder.
- •Has any severe and/or uncontrolled disease.
- •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.
- •Has participated in other clinical studies within 4 weeks before enrollment. 10.Using inhibitors or inducers of CYP3A at present.
- •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.
- •Pleural effusion, pericardial effusion or ascites that cannot be controlled and need repeated drainage.
- •Brain metastases with symptoms or symptoms of brain metastases were controlled for less than 2 weeks.
- •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.
研究组 & 干预措施
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.
干预措施: TQ-B3139 capsules (Drug)
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.
干预措施: TQ-B3139 capsules (Drug)
结局指标
主要结局
AUC0-t
时间窗: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to time.
AUC0-∞
时间窗: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
To characterize the pharmacokinetics of TQ-B3139 by assessment of area under the plasma concentration time curve from zero to infinity.
Cmax
时间窗: 0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.
Cmax is the maximum plasma concentration of TQ-B3139 or metabolite(s).
次要结局
- Tmax(0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.)
- t1/2(0hour, 1hour, 2hour, 3hour, 4hour, 5hour, 6hour, 7hour, 8hour, 10hour, 24hour, 48hour,72hour, 96hour on day 1 and day 5.)
- Progression-free survival (PFS)(up to 24 months)
- Disease control rate (DCR)(up to 24 months)
- Objective Response Rate (ORR)(up to 24 months)
- Duration of response (DOR)(up to 24 months)