This study is conducted to assess the safety, tolerability and preliminary efficacy of AST2818 in patients with advanced Non Small Cell Lung Cancer (NSCLC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
116
patients take Alflutinib orally once per day at different dose
cancer hospital Chinese academy of medical sciences
Beijing, China
Objective response rate of Alflutinib
Evaluation of objective response rate assessed by RECIST 1.1
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks.
Duration of response of Alflutinib
Duration of response assessed by RECIST 1.1
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks.
Progression free survival of Alflutinib
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate progression free survival
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks.
Clinical benefit rate of Alflutinib
Clinical benefit rate was calculated by adding up complete remission, partial remission and stabilization of disease assessed by RECIST 1.1
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks.
Disease control rate of Alflutinib
Progression of tumor was assessed by RECIST 1.1 thereby to evaluate disease control rate
Time frame: CT or MRI at screening and every 2 Cycles (from first dose of multiple dosing) until disease progression or withdrawal from study, whichever came first, assessed up to 52 weeks.
Incidence and Severity of Treatment-Emergent Adverse Events
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Assessed by number and severity of adverse events as recorded on the case report form, vital signs, laboratory variables, physical examination, electrocardiogram, ophthalmic examinations, RECIST1.1, and NCI CTCAE v4.03
Time frame: Adverse events will be collected from baseline until 28 days after the last dose
Steady state Maximum Plasma Concentration [Cmax] of multiple doses Alflutinib and 2 metabolites
Cmax of Alflutinib and 2 metabolites at steady state following multiple doses
Time frame: Blood samples will be collected from each subject at pre-specified times during the multiple dosing cycles (Cycle 1-pre-dose Day 1, 8, 15. Cycle 2 D1- pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose)
Steady state peak plasma time [tmax] of multiple doses Alflutinib and 2 metabolites
tmax of Alflutinib and 2 metabolites at steady state following multiple doses.
Time frame: Blood samples will be collected from each subject at pre-specified times during the multiple dosing cycles (Cycle 1-pre-dose Day 1, 8, 15. Cycle 2 D1- pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose)
Steady state Cmin (Minimum Plasma Concentration) of multiple doses Alflutinib and 2 metabolites
Cmin of Alflutinib and 2 metabolites at steady state following multiple doses.
Time frame: Blood samples will be collected from each subject at pre-specified times during the multiple dosing cycles (Cycle 1-pre-dose Day 1, 8, 15. Cycle 2 D1- pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose)
Steady state area under the plasma concentration versus time curve [AUC] of multiple doses Alflutinib and 2 metabolites
AUC of Alflutinib and 2 metabolites at steady state following multiple doses.
Time frame: Blood samples will be collected from each subject at pre-specified times during the multiple dosing cycles (Cycle 1-pre-dose Day 1, 8, 15. Cycle 2 D1- pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose)
Steady state clearance of multiple doses Alflutinib and 2 metabolites
Clearance of Alflutinib and 2 metabolites at steady state following multiple doses.
Time frame: Blood samples will be collected from each subject at pre-specified times during the multiple dosing cycles (Cycle 1-pre-dose Day 1, 8, 15. Cycle 2 D1- pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose)
Accumulation ratio of multiple doses Alflutinib and 2 metabolites
Accumulation ratio of Alflutinib and 2 metabolites following multiple doses.
Time frame: Blood samples will be collected from each subject at pre-specified times during the multiple dosing cycles (Cycle 1-pre-dose Day 1, 8, 15. Cycle 2 D1- pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72 hours post dose)