The phase I/II clinical study is to investigate the safety, tolerability and efficacy of ICP-022 in R/R CLL/SLL patients.
Part I: Safety evaluation -2 regimens of ICP-022 (High and low dose QD) are designed for safety assessment. The recommended dose of phase II clinical study will be determined according to the Part I results. Part II: Dose expansion -Anti-tumor effects of ICP-022 in Chinese patients with R/R CLL/SLL will be evaluated in approximately 80 subjects. The recommended Phase 2 dose will be used in the Part II.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
The drug product is a white, round, uncoated tablet.
1.Objective response rate (ORR)
The efficacy measured by overall response rate (ORR) in Part II. Efficacy was evaluated by researchers according to IWCLL2008standard and update standard (Hallek, 2012), which was defined as complete remission (CR) of CLLsubjects, complete remission with incomplete bone marrow recovery (CRi), or partial remission (PR),including nodular partial remission (nPR) and partial remission with lymphocytosis (pr-l).SLL subjectsachieved complete response (CR) or partial response (PR).
Time frame: Up to 3 years
Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria
The safety and tolerability of ICP-022 measured by the occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I
Time frame: Up to 3 years
TTR
The efficacy measured by time to response (TTR) in Part II
Time frame: Up to 3 years
TTP
The efficacy measured by time to progression (TTP) in Part II
Time frame: Up to 3 years
PFS
The efficacy measured by progression free survival (PFS) in Part II
Time frame: Up to 3 years
DOR
The efficacy measured by duration of response (DOR) in Part II
Time frame: Up to 3 years
OS
The efficacy measured by overall survival (OS) in Part II
Time frame: Up to 3 years
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Anhui Province Cancer Hospital
Hefei, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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Xiamen, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
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