Study of Tolerance and Pharmacokinetics of TQ-B3233 Capsule, phase I,single arm.
The maximum tolerated dose (MTD) of TQ-B3233 \[ Time Frame: 48 weeks \] \[ Designated as safety issue: Yes \]The highest dose at which no more than 33% of the subjects experience a dose-limiting toxicity (DLT) during treatment. Pharmacokinetics of TQ-B3233 (in whole blood):In the study of single-dose, full PK profiles will be obtained at H0/H0.5/H1/H2/H3/H5/H8/H10/H12/H24/H48/H72(H means Hour).In the study of multiple-dose,full PK profiles will be obtained at D0/D1/D2/D8/D15/D22/D28(D means Day).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
QD or BID in different stage of this research
Beijing cancer hospital
Beijing, China
RECRUITINGmaximum tolerated dose(MTD)
Time frame: 28 Days
dose-limiting toxicity(DLT)
Time frame: 28 Days
Peak Plasma Concentration(Cmax)
Time frame: up to 28 Days
Peak time(Tmax)
Time frame: up to 28 Days
Half life(t1/2)
Time frame: up to 28 Days
Area under the plasma concentration versus time curve (AUC)
Time frame: up to 28 Days
Objective Response Rate (ORR)
Time frame: up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.