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TQB3811 tablet is a second-generation tropomyosin receptor kinase (TRK) inhibitor that selectively inhibits the kinase activity of TRKA, TRKB, and TRKC, and also selectively inhibits the kinase activity of TRKA, TRKB, and TRKC that produce secondary drug-resistant mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3811 | Experimental | The initial dose is 2.5mg, once a day (QD), and the medication stage is divided into single administration and continuous administration. The single administration is given once a day, and the continuous administration is entered 4 days after drug withdrawal. The drug is administered continuously until the disease progresses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3811 | Drug | TQB3811 is a second-generation TrkA inhibitor. |
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| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | To evaluate MTD of TQB3811 tablets in Chinese adult patients with advanced solid tumors | Baseline up to 32 weeks |
| Adverse events (AEs) and serious adverse events (SAEs) | The occurrence of all AEs and SAEs | Baseline up to 28 days |
| Dose-limiting toxicity (DLT) | To evaluate DLT of TQB3811 tablets in Chinese adult patients with advanced solid tumors | Baseline up to 32 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach maximum (peak) plasma concentration following drug administration(Tmax) | To characterize the pharmacokinetics of TQB3811 by assessment of time to reach maximum plasma concentration after single and multiple dosing | 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| LIN SHEN, Master | Contact | 010-88196561 | doctorshenlin@sina.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| Maximum (peak) plasma drug concentration (Cmax) | Cmax is the maximum plasma concentration of TQB3811 or metabolite(s). | 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1. |
| Elimination half-life (t1/2) | t1/2 is time it takes for the blood concentration of TQB3811 or metabolite(s) to drop by half. | 15, 30minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11. |
| Area under the plasma concentration-time curve from time zero to time t (AUC0-t) | To characterize the pharmacokinetics of TQB3811 by assessment of area under the plasma concentration time curve from the first dose to infinity. | 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 ;30 minutes before oral administration on day 1. |
| Maximum (peak) steady-state plasma drug concentration during a dosage interval (Cmax,ss) | Cmax,ss is maximum (peak) steady-state plasma drug concentration during a dosage interval . | 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11. |
| Minimum steady-state plasma drug concentration during a dosage interval (Css-min) | Css-min is minimum steady-state plasma drug concentration during a dosage interval. | 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11. |
| Concentration at the end of the dosing interval (AUCtau,ss) | To characterize the pharmacokinetics of TQB3811 by assessment of area The concentration at the end of the administration interval | 15, 30 minutes, 1, 2, 4, 6, 8,10, 24, 48 hours after oral administration of day 1 and day 11;30 minutes before oral administration on day 1, day5, day7,day8 ,day 9 and day11. |
| Progress Free Survival(PFS) | From the start of randomization to the first tumor progression or time of death. | up to 96 weeks |
| Disease control rate(DCR) | Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 96 weeks |
| Duration of Response (DOR) | The time when the participants first achieved complete or partial remission to disease progression. | up to 96 weeks |