Active, not recruiting
Phase 1/2
A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients
Condition(s) studied
Non Hodgkin Lymphoma
Investigational drug(s) / intervention(s)
Abexinostat: Abexinostat Tosylate Tablets
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Measure AUC at Different Dose Level — Up to 6 month
Measure Area under the plasma concentration versus time curve (AUC) levels at different dose level
- Measure Cmax at Different Dose Level — Up to 6 month
Measure Peak Plasma Concentration (Cmax at different dose level
- Determine the maximum tolerated dose — Up to 6 month
Determine the maximum tolerated dose based on observed dose-limiting toxicity at different dose levels
Trial sites (4)
| Facility | City | Region | Status |
| 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 |
|
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