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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Abexinostat Tosylate Tablets
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China
Zhejiang Cancer Hospital
Hangzhou, China
Tianjin Medical University General Hospital
Tianjin, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China
Measure AUC at Different Dose Level
Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level
Time frame: Up to 6 month
Measure Cmax at Different Dose Level
Measure Peak Plasma Concentration (Cmax at different dose level
Time frame: Up to 6 month
Determine the maximum tolerated dose
Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels
Time frame: Up to 6 month
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
Time frame: Up to 12 Month
Measure Duration of Response
Measure duration of response in months at the RP2D in patients with non-Hodgkin's lymphoma who have failed standard of care
Time frame: Up to 12 Month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.