A Phase 1 interventional study of TQ-B3233 in Tumor, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Other
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).
Exclusion Criteria:
QD or BID; patients are given the doses according to the protocal, and a cycle is 28 days.
Drug: TQ-B3233
QD or BID in different stage of this research
maximum 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
Plan to share: No
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.