The aim of the study was to explore the dose-limiting toxicity (DLT) and the maximum tolerable dose (MTD) of oral administration of TG02 capsules twice a week for 4 weeks.
Using the traditional 3 +3 design, 150 mg as the initial dose and 50 mg as the increasing interval of up to 250 mg, and oral administration on the 1st, 4th, 8th, 11th, 15th, 18th, 22nd and 25th day of each 28-day cycle. Phase I clinical study to evaluate the tolerance and pharmacokinetic parameters of oral TG02 capsules.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
TG02 capsules150mg oral administration, BIW in every 28d
TG02 capsules 200mg oral administration, BIW in every 28d
TG02 capsules 250mg oral administration, BIW in every 28d
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGDose limiting toxicity (DLT)
Adverse events of level 3 or above related to the study drug occurring within 28 days after the first dose as assessed by CTCAE v5.0.
Time frame: 28 days after first dose
Maximal tolerable dose(MTD)
DLT occurs in less than 1/6 subjects, this lower dose is defined as MTD.
Time frame: 28 days after first dose
Overall response rate(ORR)
proportion of patients whose best overall response during their participation in the study is either CR or PR. The best overall response is the best response recorded from first dose until disease progression.
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.