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Per sponsor request.
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To study the pharmacokinetic characteristics of TQ-B3395 in the human body, recommend a reasonable regimen for subsequent research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3395 | Experimental | TQ-B3395 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-B3395 | Drug | TQ-B3395 p.o. qd |
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| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose (MTD) of TQ-B3395 | 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-B3395 | Subjects within 28 days after treatment appear the following toxicity reaction relate to the drug :II °or above of kidney damage,III °or above of non-hematological toxicity,IV°hematological toxicity ,Neutropenia associated with fever | For 4 weeks for DLTs. |
| Pharmacokinetics of TQ-B3395 (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/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day). | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3395 (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/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day) | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3395 (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/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | Beijing Municipality | 100021 | 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-B3395 (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/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day) | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3395 (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/H1/H2/H3/H4/H8/H11/H24/H34/H48/H58/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D4/D7/D10/D14/D21(D means Day) | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |