Status:
ACTIVE_NOT_RECRUITING
A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients
Lead Sponsor:
Xynomic Pharmaceuticals, Inc.
Collaborating Sponsors:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Conditions:
Non Hodgkin Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief 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-H...
Detailed Description
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-H...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04024696
Start Date
January 8 2020
End Date
November 30 2025
Last Update
April 10 2025
Active Locations (4)
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1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
2
Zhejiang Cancer Hospital
Hangzhou, China, 310022
3
Tianjin Medical University General Hospital
Tianjin, China, 300052
4
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, China, 221006