A Clinical Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Abexinostat in Chinese Patients
NCT04024696 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-04-10
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.
Conditions
- Non Hodgkin Lymphoma
Interventions
- DRUG
-
Abexinostat
Abexinostat Tosylate Tablets
Sponsors & Collaborators
-
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
collaborator OTHER -
Xynomic Pharmaceuticals, Inc.
lead INDUSTRY
Principal Investigators
-
Yuankai Shi, M.D.; Prof · Cancer Hospital Chinese Academy of Medical Science
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-01-08
- Primary Completion
- 2024-12-30
- Completion
- 2025-11-30
Countries
- China
Study Locations
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