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TQB3616 may work in cancer by stopping cancer cells from multiplying.TQB3616 is in a new class of drugs called CDK inhibitors.This research study is the first time that TQB3616 will be given to people.TQB3616 is taken by mouth daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB3616 | Experimental | TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m to 120mg once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB3616 | Drug | TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m,40mg,60mg,80mg,100mg,120mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose-Limiting Toxicities | Baseline up to 28 days |
| MTD | Maximum Tolerated Dose | Baseline up to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum Observed Plasma Concentration | Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28 |
| Tmax |
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Inclusion Criteria:
3)Doppler ultrasound evaluation: Left ventricular ejection fraction(LVEF)≥50% 5.Patients should be voluntary and sign the informed consent before taking part in the study
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fifth Medical Center of Chinese People's Liberation Army General Hospital | Beijing | Beijing Municipality | 100039 | China | ||
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Maximum Observed Plasma Concentration |
| Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28 |
| t1/2 | Terminal Half-life | Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28 |
| AUC | Area Under the Curve | Hour 0(pre-dose),1,2,4,6,8,12,24,36,48,72,120,168hours post-dose on single dose ; Hour 0(pre-dose) of day1,day7,day14,day21,day28 on multiple dose and Hour 0(pre-dose),1,2,4,6,8,12,24hours post-dose on multiple dose of day28 |
| The Fourth Hospital of Hebei Medical University and Hebei |
| Shijiazhuang |
| Hebei |
| 050011 |
| China |
| Henan Cancer Hospital | Zhengzhou | Henan | 45008 | China |
| Jiangsu Province Hospital | Nanjing | Jiangsu | 212028 | China |