A Phase I Study of TQ-B3101 on Tolerance and Pharmacokinetics
- Registration Number
- NCT03019276
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
To study the pharmacokinetic characteristics of TQ-B3101 in the human body, recommend a reasonable regimen for subsequent research.
- Detailed Description
single arm, single or repeat dosing of TQ-B3101 on patients with solid tumors.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Histological documentation of Advanced solid tumors
- Lack of the standard treatment or treatment failure
- 18-70years,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
- Patients with treatment failure by ALK/ROS1 inhibitor
- Patients with anti-teratment,radiotherapy or surgery within 4 weeks
- Patients participated in other anticancer drug clinical trials within 4 weeks or ALK/ROS1 inhibitor within 1 week
- Blood pressure unable to be controlled(systolic pressure>140 mmHg，diastolic pressure>90 mmHg). Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQ-B3101 TQ-B3101 TQ-B3101 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
- Primary Outcome Measures
Name Time Method The maximum tolerated dose (MTD) of TQ-B3101 48 weeks The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment
The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3101 For 4 weeks for DLTs Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug ：III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever
Pharmacokinetics of TQ-B3101 (in whole blood):Peak Plasma Concentration(Cmax) 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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Pharmacokinetics of TQ-B3101 (in whole blood):Peak time（Tmax） 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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Pharmacokinetics of TQ-B3101 (in whole blood):Half life（t1/2） 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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Pharmacokinetics of TQ-B3101 (in whole blood):Area under the plasma concentration versus time curve (AUC) 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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
Pharmacokinetics of TQ-B3101 (in whole blood):Clearance（CL） 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 H-24/H-12/H0/H0.5/H1/H2/H3/H4/H6/H10/H24/H36/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D8/D15/D21/D28（D means Day）
- Secondary Outcome Measures
Name Time Method Objective Response Rate(ORR) each 28 days up to intolerance the toxicity or PD (up to 24 months) Percentage of participants with OR based assessment of confirmed complete remission (CR) or confirmed partial remission (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST).
Trial Locations
- Locations (1)
Sir Run Run Shaw Hospital,School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China