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

An Open-Label, Non-Randomized Clinical Study to Evaluate Pharmacokinetic (PK) Profiles, Safety, and Tolerability of Abexinostat Monotherapy in Patients With Non-Hodgkin's Lymphoma Who Have Failed Standard of Care

Sponsors

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Collaborator: Chinese Academy of Medical Sciences

Source Xynomic Pharmaceuticals, Inc.
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-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.

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-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. Three (3) dose groups are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC). A total of 12-16 subjects in the RP2D dose group will be required to accept PK blood sampling for the analysis of PK profiles and parameters. The patients will continue treatment until the occurrence of a DLT event, disease progression, intolerant toxicity, withdrawal of ICF, treatment discontinuation determined by the investigator, lost to follow-up, death, or termination of the study, (whichever occurs first).

Overall Status Recruiting
Start Date 2020-01-08
Completion Date 2021-12-31
Primary Completion Date 2021-12-31
Phase Phase 1/Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Measure AUC at Different Dose Level Up to 6 month
Measure Cmax at Different Dose Level Up to 6 month
Determine the maximum tolerated dose Up to 6 month
Secondary Outcome
Measure Time Frame
Measure Objective Response Rate Up to 12 Month
Measure Duration of Response Up to 12 Month
Enrollment 25
Condition
Intervention

Intervention Type: Drug

Intervention Name: Abexinostat

Description: Abexinostat Tosylate Tablets

Arm Group Label: Dosing Cohorts

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Yuankai Shi, M.D.; Prof Principal Investigator Cancer Hospital Chinese Academy Of Medical Science
Overall Contact

Last Name: Bing Zhao, MD

Phone: (01186)13716386801

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Cancer Hospital Chinese Academy of Medical Sciences | Beijing, 100021, China Recruiting Shi Yuankai, MD, PhD 13701251865 [email protected] Shao Zonghong, MD Principal Investigator
Zhejiang Cancer Hospital | Hangzhou, 310022, China Recruiting Yang Haiyan, MD, PhD 13857182590 [email protected]
Tianjin Medical University General Hospital | Tianjin, 300052, China Recruiting Shao Zonghong, MD 13802036467 [email protected]
The Affiliated Hospital of Xuzhou Medical University | Xuzhou, 221006, China Recruiting Li Zhenyu, MD 13852439312 [email protected]
Location Countries

China

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Dosing Cohorts

Type: Experimental

Description: Three (3) dose cohorts are pre-set to include 40 mg BID, 60 mg BID and 80 mg BID,respectively.The pre-set dose group is subject to change during the study and the actual dosage increment is determined by the Data safety Monitoring Committee (DSMC).

Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Sequential Assignment

Intervention Model Description: Cohort 1: 40 mg BID Cohort 2: 60 mg BID Cohort 3: 80 mg BID

Primary Purpose: Treatment

Masking: None (Open Label)

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