A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04024696|
Recruitment Status : Not yet recruiting
First Posted : July 18, 2019
Last Update Posted : July 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non Hodgkin Lymphoma||Drug: Abexinostat||Phase 1 Phase 2|
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 occurance 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care|
|Estimated Study Start Date :||October 15, 2019|
|Estimated Primary Completion Date :||October 15, 2020|
|Estimated Study Completion Date :||April 15, 2021|
Experimental: Dosing Cohorts
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).
Abexinostat Tosylate Tablets
- Measure AUC at Different Dose Level [ Time Frame: Up to 6 month ]Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level
- Measure Cmax at Different Dose Level [ Time Frame: Up to 6 month ]Measure Peak Plasma Concentration (Cmax at different dose level
- Determine the maximum tolerated dose [ Time Frame: Up to 6 month ]Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels
- Measure Objective Response Rate [ Time Frame: Up to 12 Month ]Measure objective response rate in % at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care
- Measure Duration of Response [ Time Frame: Up to 12 Month ]Measure duration of response in months at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04024696
|Contact: Bing Zhao, MD||(01186)email@example.com|
|Contact: Sophia Paspal, Ph.Dfirstname.lastname@example.org|
|Principal Investigator:||Yuankai Shi, M.D.; Prof||Cancer Hospital Chinese Academy Of Medical Science|