NCT04390984Unknown1 期
A Multi-center, Open-label, Fixed-sequence Study of Effect of Gefitinib on the Pharmacokinetics of Apatinib Mesylate in Non-squamous, Non-small-cell Lung Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The primary objective of the study was to assess the effect of gefitinib on the pharmacokinetics of apatinib mesylate in lung cancer patients.
The secondary objective of the study was to assess the pharmacokinetics of gefitinib, and to assess the safety of apatinib mesylate and gefitinib administered in lung cancer patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age.
- •ECOG performance status: level 0~1;
- •Anticipated life expectancy ≥ 12 weeks;
- •Lung cancer patients;
- •Major organs in good function;
- •Agree to take approved method of contraception during the clinical trail and 8 weeks after the last dose of apatinib. Female subject should be negative in the pregnancy test;
- •Able to comprehend and willing to sign an informed consent form (ICF)
排除标准
- •History of drug allergy, or allergic to apatinib or gefitinib or ingredients;
- •Squamous cancer, small-cell lung cancer;
- •Symptomatic central nervous system (CNS) metastases
- •Hypertension and couldn't be controlled with medicine;
- •Coagulation disorders;
- •Clinical significant bleeding in 3 months prior dosing;
- •Had surgery in four weeks prior dosing;
- •Disease that affect drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction;
- •Abdominal fistula, gastrointestinal perforation or intraperitoneal abscess in 6 months prior dosing;
- •Urine protein ≥++, and urine protein ≥1.0g in 24 hours;
- •Active infection and need antimicrobial treatments;
- •History of psychiatric substance abuse;
- •Take any clinical trial drugs within four weeks prior dosing;
- •Take any drugs that have effect on gastric acid and metabolic enzyme CYP 3A and CYP2D6;
- •Combined with other viral infections (anti-HCV, anti-HIV positive, HBsAg positive) or combined with syphilis infection;
- •Addicted to alcohol and tobacco;
- •Take grapefruit or grapefruit product, drinks containing caffeine, xanthine and alcohol in 48 hours prior dosing;
- •The investigator believes that the subjects are not eligible to participate in this trial.
研究组 & 干预措施
1
Experimental
Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.
干预措施: Apatinib Mesylate, Gefitinib (Drug)
结局指标
主要结局
Cmax
时间窗: 0-24 hours
Maximum Observed Plasma Concentration for apatinib
AUC0-τ
时间窗: 0-24 hours
Area Under the Concentration-time Curve From Zero (Pre-dose) to 24 hours
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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