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| Name | Class |
|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | OTHER |
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This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
This is an open-label, non-randomized clinical study to evaluate the pharmacokinetic (PK) profiles, safety, tolerability and preliminary efficacy of oral abexinostat monotherapy in patients with non-Hodgkin's lymphoma who have failed standard of care, and thereby to determine the pharmacokinetic (PK) parameters, the maximum tolerated dose (MTD), and the recommended phase 2 dose (RP2D) of the oral monotherapy of abexinostat.
Three (3) dose groups are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). A total of 12-16 subjects in the RP2D dose group will be required to accept PK blood sampling for the analysis of PK profiles and parameters. The patients will continue treatment until the occurrence of a DLT event, disease progression, intolerant toxicity, withdrawal of ICF, treatment discontinuation determined by the investigator, lost to follow-up, death, or termination of the study, (whichever occurs first).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosing Cohorts | Experimental | Three (3) dose cohorts are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abexinostat | Drug | Abexinostat Tosylate Tablets |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure AUC at Different Dose Level | Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level | Up to 6 month |
| Measure Cmax at Different Dose Level | Measure Peak Plasma Concentration (Cmax at different dose level | Up to 6 month |
| Determine the maximum tolerated dose | Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels | Up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| Measure Objective Response Rate | Measure objective response rate in % at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care | Up to 12 Month |
| Measure Duration of Response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuankai Shi, M.D.; Prof | Cancer Hospital Chinese Academy of Medical Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Sciences | Beijing | 100021 | China | |||
| Zhejiang Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40442628 | Derived | Gui L, Xie Z, Qin Y, Liu P, Yang J, Chen X, Li Z, Tao R, Shi Y. Safety, pharmacokinetics, and efficacy of abexinostat, an novel histone deacetylase inhibitor, in Chinese patients with relapsed/refractory B cell non-Hodgkin lymphoma: a Phase 1 study. BMC Cancer. 2025 May 30;25(1):967. doi: 10.1186/s12885-025-14370-y. |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C512352 | abexinostat |
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Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID
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Measure duration of response in months at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care
| Up to 12 Month |
| Hangzhou |
| 310022 |
| China |
| Tianjin Medical University General Hospital | Tianjin | 300052 | China |
| The Affiliated Hospital of Xuzhou Medical University | Xuzhou | 221006 | China |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |