TQB3303 tablet is a small molecule oral drug inhibiting cyclin-dependent kinases 4 and 6 (CDK4 / 6). Based on current research, overexpression of positive regulatory proteins in the cell cycle is one of the important reasons for resistance to endocrine therapy. CDK4 / 6 is the key regulators of the cell cycle inhibiting tumor cell proliferation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
TQB3303 tablet is a small molecule oral drug inhibiting cyclin-dependent kinases 4 and 6 (CDK4 / 6).
Chinese Academy of Medical Sciencesand Peking Union Medical College
Beijing, Beijing Municipality, China
Dose-limiting toxicity (DLT)
Subjects appear the following toxic reaction relate to the drug after treatment within 28 days :III °or above of non-hematological toxicity, IV° hematological toxicity , III ° neutropenia associated with fever, III ° thrombocytopenia with bleeding, III ° QTc interval extended
Time frame: Baseline up to 28 days
Cmax
Cmax is the maximum plasma concentration of TQB3303 or metabolite(s).
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on single dose; Hour 0 of day 7,day 14,day21 on multiple dose and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on multiple dose of day 28.
Tmax
To characterize the pharmacokinetics of TQB3303 by assessment of time to reach maximum plasma concentration.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on single dose; Hour 0 of day 7,day 14,day21 on multiple dose and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on multiple dose of day 28.
AUC0-t
To characterize the pharmacokinetics of TQB3303 by assessment of area under the plasma concentration time curve from zero to infinity.
Time frame: Hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on single dose; Hour 0 of day 7, day 14, day21 on multiple dose and hour 0, 0.5, 1, 2, 3, 4, 6, 8, 11, 24, 48, 72, 120 hours post-dose on multiple dose of day 28.
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 96 weeks
Disease control rate(DCR)
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Percentage of participants achieving Complete Response (CR) and Partial Response (PR) and Stable Disease (SD).
Time frame: up to 96 weeks
Duration of response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: up to 96 weeks
Progression-free survival (PFS)
PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause.
Time frame: up to 96 weeks