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

This is an interventional treatment trial for Non Hodgkin Lymphoma Read More

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.