A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xynomic Pharmaceuticals, Inc.
• Collaborator: Chinese Academy of Medical Sciences
• Treatments: Abexinostat

Criteria

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 immunodeficiency virus (HIV) infection , or hepatitis C (HCV) hepatitis virus infection PCR RNA positive);

• Uncontrolled systemic infection or infection requiring intravenous injection of antibiotics

• Lymphoma with central nervous system (CNS) involvement

• Subjects with concurrent other malignant tumors in addition to the studied tumor within 2 years prior to the first dosing , except for the controlled skin basal cell carcinoma , cervical carcinoma in situ, ductal carcinoma in situ , and papillary thyroid carcinoma

• Subject is known to be allergic to the components of abexinostat

• Pregnant and lactating subjects

• Upon the investigator's judgment , the subject has any disease or medical condition that is unstable or may affect safety or study compliance , such as uncontrolled hypertension,uncontrolled diabetes, active bleeding , etc.