A Multi-center, Non-Randomized, Open-Label Phase 2 Basket Clinical Trial to Evaluate ICP-723 in Patients with Advanced Solid Tumors or Primary Central Nervous System Tumors
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
70
ICP-723 tablet administered orally,once a day,for every 28 days as one cycle
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
The objective response rate (ORR) evaluated by the Independent Center Review
Time frame: Through study completion, an average of 4 years
ORR assessed by the investigator
Time frame: Through study completion, an average of 4 years
DCR as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Time to response (TTR) as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Duration of response (DOR) as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Progression-free survival (PFS) as assessed by the investigator and the IRC
Time frame: Through study completion, an average of 4 years
Intracranial objective response rate (IC-ORR) as assessed by the investigator and IRC
Time frame: Through study completion, an average of 4 years
central nervous system progression-free survival (CNS-PFS) as assessed by the investigator and IRC
Time frame: Through study completion, an average of 4 years
Overall survival (OS)
Time frame: Through study completion, an average of 4 years
The incidence, character and severity of adverse events as assessed per NCI-CTCAE v5.0 criteria
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Time frame: Through study completion, an average of 4 years
The maximum plasma concentration observed (Cmax)
Time frame: Through study completion, an average of 4 years
Time of maximum observed plasma concentration (Tmax)
Time frame: Through study completion, an average of 4 years
Elimination half-life (t1/2)
Time frame: Through study completion, an average of 4 years
AUC0-∞
Time frame: Through study completion, an average of 4 years
AUC0-t
Time frame: Through study completion, an average of 4 years
Apparent clearance (CL/F)
Time frame: Through study completion, an average of 4 years
Apparent volume of distribution (Vz/F)
Time frame: Through study completion, an average of 4 years