Phase I Study of Tolerance and Pharmacokinetics of TQ-B3395 in Patients With Advanced Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Pharmacokinetics of TQ-B3395 (in whole blood):Peak time（Tmax）
研究概览
简要总结
To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological documentation of Advanced solid tumors,lack of the standard treatment or treatment failure.In expanding stage,enroll the Non-small Cell Lung Cancer with EGFR+(except exon 20)
- •18-70 years,ECOG PS:0-1,Life expectancy of more than 3 months
- •Main organs function is normal
- •Women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；Man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped
- •Patients should participate in the study voluntarily and sign informed consent
排除标准
- •14 Days or more from the last cytotoxic therapy
- •Patients participated in other anticancer drug clinical trials within 4 weeks or Patients participating in other clinical trials now
- •Blood pressure unable to be controlled ideally by one drug(systolic pressure≥140 mmHg，diastolic pressure≥90 mmHg); Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc≥470ms) and patients with Grade 3 or higher congestive heart failure (NYHA Classification)
- •Patients with non-healing wounds or fractures
- •Patients with drug abuse history and unable to get rid of or Patients with mental disorders
- •History of immunodeficiency
- •Patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment
研究组 & 干预措施
TQ-B3395
TQ-B3395 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
干预措施: TQ-B3395 (Drug)
结局指标
主要结局
Pharmacokinetics of TQ-B3395 (in whole blood):Peak time（Tmax）
时间窗: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）
Pharmacokinetics of TQ-B3395 (in whole blood):Clearance（CL）
时间窗: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Clearance（CL）,CL in L/h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）
Pharmacokinetics of TQ-B3395 (in whole blood):Area under the plasma concentration versus time curve (AUC)
时间窗: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Area under the plasma concentration versus time curve (AUC), AUC in ng.h/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）
The maximum tolerated dose (MTD) of TQ-B3395
时间窗: 48 weeks
The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
Pharmacokinetics of TQ-B3395 (in whole blood):Half life（t1/2）
时间窗: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）
The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3395
时间窗: For 4 weeks for DLTs.
Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：II °or above of kidney damage，III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever
Pharmacokinetics of TQ-B3395 (in whole blood):Peak Plasma Concentration(Cmax)
时间窗: up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL)
Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21（D means Day）.
次要结局
- Objective Response Rate (ORR)(each 56 days up to intolerance the toxicity or PD (up to 24 months))