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To study the pharmacokinetic characteristics of TQ-B3234 in the human body, recommend a reasonable regimen for subsequent research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3234 | Experimental | TQ-B3234 QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3234 | Drug | TQ-B3234 p.o. qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose (MTD) of TQ-B3234 | Yes ]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment | 48 weeks |
| The type of dose-limiting toxicity(ies) (DLT[s]) of TQ-B3234 | 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 | For 4 weeks for DLTs |
| Pharmacokinetics of TQ-B3234 (in whole blood):Peak Plasma Concentration(Cmax) | Peak Plasma Concentration(Cmax),Cmax in ng/mL.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/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/D22/D23/D25/D28（D means Day） | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3234 (in whole blood):Peak time（Tmax） | Peak time（Tmax）,Tmax in h.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/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/D22/D23/D25/D28（D means Day） | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3234 (in whole blood):Half life（t1/2） | Half life（t1/2）,t1/2 in h.In the study of single-dose, full PK profiles will be obtained at H0/H0.5/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/D22/D23/D25/D28（D means Day） |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | each 56 days up to intolerance the toxicity or PD (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiubao Ren, doctor | Contact | 022-23340123 | rwziyi@yahoo.com | |
| Zhao Yan, pharmacist | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3234 (in whole blood):Area under the plasma concentration versus time curve (AUC) | 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/H0.5/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/D22/D23/D25/D28（D means Day） | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3234 (in whole blood):Clearance（CL） | Clearance（CL）,CL in L/h.In the study of single-dose,full PK profiles will be obtained at H0/H0.5/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/D22/D23/D25/D28（D means Day） | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |