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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NTQ2494 | Experimental | For each dose level, multiple doses of NTQ2494 tablets will be administered as 28-day treatment (per cycle). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NTQ2494 tablet | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum 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. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of single dose | At the end of Cycle 1 (each cycle is 28 days) | |
| AUC0-t of single dose | At the end of Cycle 1 (each cycle is 28 days) | |
| AUC0-∞ of single dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yu meng Zhou | Contact | 86-025-85109999 | yumeng_zhou@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hematology Hospital of the Chinese Academy of Medical Sciences | Recruiting | Tianjin | Tianjin Municipality | 300000 | China |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| At the end of Cycle 1 (each cycle is 28 days) |
| Tmax of single dose | At the end of Cycle 1 (each cycle is 28 days) |
| t1/2z of single dose | At the end of Cycle 1 (each cycle is 28 days) |
| Vz/F of single dose | At the end of Cycle 1 (each cycle is 28 days) |
| CLz/F of single dose | At the end of Cycle 1 (each cycle is 28 days) |
| λz of single dose | At the end of Cycle 1 (each cycle is 28 days) |
| MRT0-t of single dose | At the end of Cycle 1 (each cycle is 28 days) |
| Rac of AUC and Cmax of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| DF of AUC and Cmax of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| Css,max of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| Css,min of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| AUCss of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| Cav of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| Tss,max of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| t1/2 of first 28 days of multiple doses | 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. | At the end of Cycle 1 (each cycle is 28 days) |
| CLss/F of first 28 days of multiple doses | At the end of Cycle 1 (each cycle is 28 days) |
| λz of first 28 days of multiple doses | 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. | 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. | 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. | 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. | through study completion, an average of 1 year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |