A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese… (NCT04024696) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients
China12 participantsStarted 2020-01-08
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Histologically confirmed diagnosis o f non Hodgkin's lymphoma
* Patients with non-Hodgkin's lymphoma who have either failed standard of care or are intolerant/unapplicable to therapy;
* Subject who has no growth factor supportive therapy, transfusion of blood or blood products within 14 days before the enrollment test
* The patient is capable and willing to accept the follow up according to the protocol and signed or provided the ICF signed by the legal representative
* Contraceptive measures , definition of women of childbearing age and contraceptive requirements
Exclusion Criteria:
* Subjects who have received anti tumor therapy and have not recovered from previous toxicity reactions ( toxicity reactions unrecovered to grade 1 as per NCI CTCAE 5.0
* Subjects who received major surgery (excluding diagnostic biopsy)within 28 days prior to the first dose.
* Subjects who received autologous stem cell transplantation within 3 months or allogeneic stem cell transplantation within 6 months prior to the first dose with active graft versus host response at screening
* Subjects with use of prohibited medication within 7 days or less than 5 half lives prior to the first dose (whichever is shorter), see prohibited medication list
* Participated in other interventional clinical trial within 1 month or 5 half life periods prior to the first dose (whichever is longer), except for non intervention clinical trials
* Evidence suggests that there may be human immunode…