A Phase I Study of TQ-B3139 on Tolerance and Pharmacokinetics
- Registration Number
- NCT03099330
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Brief Summary
A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer
- Detailed Description
phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- Histological documentation of Advanced solid tumors
- Lack of the standard treatment or treatment failure
- 18-65years,ECOG PS:0-1,Life expectancy of more than 3 months
- Patients with anti-treatment or surgery within 4 weeks
- 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 participated in other anticancer drug clinical trials within 4 weeks
- 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-B3139 TQ-B3139 TQ-B3139 p.o. qd
- Primary Outcome Measures
Name Time Method Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
The maximum tolerated dose (MTD) of TQ-B3139 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-B3139 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-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/D8/D15/D21/D28（D means Day）.
Pharmacokinetics of TQ-B3139 (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 H0/H1/H2/H3/H4/H6/H10/H24/H34/H48/H72/H96/H120/H144（H means Hour）.In the study of multiple-dose,full PK profiles will be obtained at D1/D4/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)
Trial Locations
- Locations (1)
Sun-Yat-Sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China