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A study of TQ-B3139, inhibitor of ALK/C-Met tyrosine kinase, in patient with advanced cancer
phase I of safety, pharmacokinetic and pharmacodynamic study of TQ-B3139. To recommend a reasonable dose and indication for subsequent research.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQ-B3139 | Experimental | TQ-B3139 p.o. qd |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQ-B3139 | Drug | TQ-B3139 p.o. qd |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum tolerated dose (MTD) of TQ-B3139 | 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-B3139 | 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-B3139 (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/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). | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3139 (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/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). | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3139 (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/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). | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | each 28 days up to intolerance the toxicity or PD (up to 24 months) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with Grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QT≥470ms)
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhang, doctor | Contact | 020-87343088 | Zhangli6@mail.sysu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun-Yat-Sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35940055 | Derived | Ma Y, Zhao H, Xue J, Liu L, Yang N, Zhang Y, Yang H, Hong S, Xiong Y, Zhang Z, Zeng L, Pan H, Zhou C, Zhang Y, Wang X, Han X, Wan X, Shao Y, Liu J, Yang Y, Huang Y, Zhao Y, Fang W, Li S, Zhang L. First-in-human phase I study of TQ-B3139 (CT-711) in advanced non-small cell lung cancer patients with ALK and ROS1 rearrangements. Eur J Cancer. 2022 Sep;173:238-249. doi: 10.1016/j.ejca.2022.06.037. Epub 2022 Aug 5. |
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| Pharmacokinetics of TQ-B3139 (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/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). | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |
| Pharmacokinetics of TQ-B3139 (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/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). | up to 28 Days (endpoint when the two consecutive time points of blood drug concentration <150 DPM/mL) |