Advanced Cancer
Conditions
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.
Interventions
DRUGTQ-B3101
Escalating doses of TQ-B3101 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 100 mg to 500 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days .
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 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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） |
| 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） |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Contacts
Primary ContactHongming Pan, Doctor
Outcome results
None listed