This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
ICP-192 is a round, uncoated tablet, 4mg, 5mg. It is administered orally at the dose of 20 mg/day from day 1 to day 21 of each cycle until progression
Objective response rate (ORR)
ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
Time frame: From the time of first dose until objective disease progression, an average of 6 months
Duration of response (DOR)
DOR is time interval from the first date that criteria for complete response or partial response are met to the first date of progression of disease
Time frame: From the time of first dose until objective disease progression, an average of 6 months
Disease Control Rate (DCR)
DCR based on assessment of confirmed Complete response (CR), partial response (PR) or stable disease(SD) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
Time frame: From the time of first dose until objective disease progression, an average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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