The phase II clinical study is to investigate the safety, tolerability, efficacy and pharmacokinetics of ICP-022. Safety, tolerability evaluation, and anti-tumor effects of ICP-022 in Chinese patients with R/R MZL will be evaluated in approximately 110 subjects. Pharmacokinetics of ICP-022 will be evaluated in approximately 20 subjects.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
111
ICP-022 (tablets, 50 mg) is given orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
Overall Response Rate (ORR)
The efficacy measured by overall response rate (ORR) in Part II according to the 2014 International Working Group NHL
Time frame: Up to 3 years
Occurrence of adverse events and serious adverse events according to NCI-CTCAE 4.03 grading criteria in Part I
The safety 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
Progressioin free survival (PFS)
Progression free survival (PFS) is defined as the time from registration to the first occurrence of progression or relapse as assessed by the investigator, or death from any cause. PFS for patients without disease progression, relapse, or death will be censored at the time of the last tumor assessment.
Time frame: Up to 3 years
Duration of Response (DR)
Duration of response as defined as the period from the first response (at least PR) to treatment until evidence of disease progression, relapse or death of any cause. Patients alive without progression and relapse will be censored at the latest tumor assessment date or the stopping date.
Time frame: Up to 3 years
Overall survival (OS)
Overall survival is defined as the period from the induction registration to death from any cause. Patients who have not died until the time of the analysis will be censored at their last contact date.
Time frame: Up to 3 years
Area under the concentration time curve up to the time "t" (AUC(0-t))
Area under the concentration time curve up to the time "t" (AUC(0-t)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
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Anhui Provincial Hospital
Hefei, Anhui, China
Anhui Cancer Hospital
Hefei, Anhui, China
Chinese People's Liberation Army General Hospital Fifth Medical Center
Beijing, Beijing Municipality, China
Peking university People's Hospital
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Union Hospital Affiliated to Fujian Medical University
Fuzhou, Fujian, China
The Second Hospital of Lanzhou University
Lanzhou, Gansu, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China
...and 22 more locations
Time frame: up to 4 weeks
Maximum plasma drug concentrations (Cmax)
Individual plasma concentrations of ICP-022 will be measured and Cmax will be calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 4 weeks
Time of maximum plasma drug concentrations (Tmax)
Time of maximum plasma drug concentrations (Tmax) of ICP-022 will be recorded.
Time frame: up to 4 weeks
Apparent half-life for designated elimination phases (t½)
Apparent half-life for designated elimination phases (t½) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 4 weeks
Area under the concentration time curve up to the last data point above LOQ (AUC(last))
Area under the concentration time curve up to the last data point above LOQ (AUC(last)) of ICP-022 will be measured and calculated with noncompartmental analysis using WinNonlin.
Time frame: up to 4 weeks