NTQ2494 tablet, an anti-tumor molecular targeted drug, is an AXL kinase inhibitor. The objectives were to evaluate the safety and tolerability, PK characteristics and preliminary efficacy of NTQ2494 tablets in patients with advanced hematological malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
72
Drug: NTQ2494 tablet Part 1: Dose escalation, single and multiple doses of NTQ2494 with dose modifications based on tolerability criteria. For each dose level, a single dose of NTQ2494 tablets will be first administered orally, then continuous 28-day treatment will start (per cycle). Part 2: Dose expansion, recommended doses from Part 1. For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle).
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China
RECRUITINGMaximum tolerance dose (MTD) and dose limiting toxicity (DLT)
MTD is defined as the maximum dose level at which no more than 1 of 3 participants experience a DLT within the days of single dose and the first 28 days of multiple doses in dose escalation part.
Time frame: 30 days
Cmax of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
AUC0-t of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
AUC0-∞ of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Tmax of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
t1/2z of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Vz/F of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
CLz/F of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
λz of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
MRT0-t of single dose
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Rac of AUC and Cmax of first 28 days of multiple doses
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Time frame: At the end of Cycle 1 (each cycle is 28 days)
DF of AUC and Cmax of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Css,max of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Css,min of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
AUCss of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Cav of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Tss,max of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
t1/2 of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Vz/F of first 28 days of multiple doses
、Vz/F、CLss/F、λz of first 28 days of multiple doses.
Time frame: At the end of Cycle 1 (each cycle is 28 days)
CLss/F of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
λz of first 28 days of multiple doses
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Objective response rate (ORR)
ORR is defined as the proportion of subjects with confirmed CRc or PR.
Time frame: through study completion, an average of 1 year
Composite response (CRc) rate
CRc rate is defined as the proportion of subjects with confirmed CR or CRi or CRh.
Time frame: through study completion, an average of 1 year
Duration of response (DOR)
DOR is defined as the duration from the date of the first documented response of CR or PR to the date of the first documented recurrence or death.
Time frame: through study completion, an average of 1 year
Recurrence-free survival (RFS)
RFS is defined as the duration from the date of the first documented response of CRc to the date of the first documented recurrence or death.
Time frame: through study completion, an average of 1 year