Advanced Cancer
Conditions
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.
Interventions
DRUGTQ-B3139
TQ-B3139 p.o. qd
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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）. |
| 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 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）. |
| 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）. |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate (ORR) | each 28 days up to intolerance the toxicity or PD (up to 24 months) |
Countries
China
Contacts
Primary ContactLi Zhang, doctor
Outcome results
None listed