Abexinostat

Generic Name: Abexinostat

Drug Type: Small Molecule

Chemical Formula: C_₂₁H_₂₃N_₃O_₅

CAS Number: 783355-60-2

Unique Ingredient Identifier: IYO470654U

Background: Abexinostat has been used in trials studying the treatment of Sarcoma, Lymphoma, Leukemia, Lymphocytic, and Hodgkin Disease, among others. It is a novel, broad-spectrum hydroxamic acid-based inhibitor of histone deacetylase (HDAC) with potential antineoplastic activity.

Clinical Trials

A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma

Phase 1

Recruiting

Conditions: Anaplastic Astrocytoma
Glioblastoma
Gliosarcoma
Recurrent High Grade Glioma
Anaplastic Oligodendroglioma

Interventions: Drug: PCI 24781
Drug: Temozolomide

First Posted Date: 2023-01-26

Last Posted Date: 2025-05-20

Lead Sponsor: University of Nebraska

Target Recruit Count: 24

Registration Number: NCT05698524

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States

Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer

Phase 1

Withdrawn

Conditions: Anatomic Stage III Breast Cancer AJCC v8
Anatomic Stage IIIA Breast Cancer AJCC v8
Anatomic Stage IIIB Breast Cancer AJCC v8
Anatomic Stage IIIC Breast Cancer AJCC v8
Anatomic Stage IV Breast Cancer AJCC v8
Hormone Receptor Positive Breast Carcinoma
Locally Advanced Breast Carcinoma
Metastatic Breast Carcinoma
Metastatic Endometrioid Adenocarcinoma
Metastatic Primary Peritoneal Carcinoma

Interventions: Drug: Abexinostat Tosylate
Drug: Fulvestrant
Drug: Palbociclib

First Posted Date: 2020-08-04

Last Posted Date: 2021-05-18

Lead Sponsor: Pamela Munster

Registration Number: NCT04498520

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

Phase 1

Active, not recruiting

Conditions: Non Hodgkin Lymphoma

Interventions: Drug: Abexinostat

First Posted Date: 2019-07-18

Last Posted Date: 2025-04-10

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Target Recruit Count: 12

Registration Number: NCT04024696

Locations: 🇨🇳
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China
🇨🇳
Tianjin Medical University General Hospital, Tianjin, China
🇨🇳
The Affiliated Hospital of Xuzhou Medical University, Xuzhou, China

and more 1 locations

Abexinostat and Ibrutinib in Diffuse Large B-cell Lymphoma and Mantle Cell Lymphoma

Phase 1

Completed

Conditions: Mantle Cell Lymphoma
Diffuse Large B-cell Lymphoma

Interventions: Drug: Abexinostat
Drug: Ibrutinib

First Posted Date: 2019-05-06

Last Posted Date: 2025-04-25

Lead Sponsor: Memorial Sloan Kettering Cancer Center

Target Recruit Count: 15

Registration Number: NCT03939182

Locations: 🇺🇸
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
🇺🇸
Memorial Sloan Kettering Commack, Commack, New York, United States
🇺🇸
Memorial Sloan Kettering Westchester, Harrison, New York, United States

and more 4 locations

Study to Evaluate Efficacy and Safety of Oral Abexinostat in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

Phase 2

Recruiting

Conditions: Diffuse Large B-cell Lymphoma (DLBCL)

Interventions: Drug: abexinostat

First Posted Date: 2019-05-03

Last Posted Date: 2025-04-10

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Target Recruit Count: 170

Registration Number: NCT03936153

Locations: 🇨🇳
Cancer Center of Guangzhou Medical University, Guangzhou, China
🇨🇳
The First Affiliate Hospital of Dalian Medical University, Dalian, China
🇨🇳
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

and more 20 locations

A Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of Oral Abexinostat as Monotherapy in Patients With Relapsed or Refractory Follicular Lymphoma

Phase 2

Active, not recruiting

Conditions: Lymphoma, Follicular

Interventions: Drug: Abexinostat

First Posted Date: 2019-05-02

Last Posted Date: 2025-04-10

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Target Recruit Count: 87

Registration Number: NCT03934567

Locations: 🇨🇳
China-Japan Friendship Hospital, Beijing, China
🇨🇳
Cancer Center of Guangzhou Medical University, Guangzhou, China
🇨🇳
Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China

and more 23 locations

Study of Abexinostat in Patients With Relapsed or Refractory Follicular Lymphoma

Phase 2

Active, not recruiting

Conditions: Follicular Lymphoma

Interventions: Drug: Abexinostat

First Posted Date: 2018-07-26

Last Posted Date: 2025-04-10

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Target Recruit Count: 139

Registration Number: NCT03600441

Locations: 🇫🇷
Centre Hospitalier de Perpignan, Perpignan, Pyrénées-Orientales, France
🇪🇸
C.H. Regional Reina Sofia, Córdoba, Spain
🇪🇸
Hospital del Mar, Barcelona, Spain

and more 12 locations

A Study of Pazopanib With or Without Abexinostat in Patients With Locally Advanced or Metastatic Renal Cell Carcinoma (RENAVIV)

Phase 3

Recruiting

Conditions: Renal Cell Carcinoma

Interventions: Drug: Pazopanib
Other: Placebo
Drug: Abexinostat

First Posted Date: 2018-07-19

Last Posted Date: 2025-04-13

Lead Sponsor: Xynomic Pharmaceuticals, Inc.

Target Recruit Count: 413

Registration Number: NCT03592472

Locations: 🇪🇸
H.U. Virgen de la Victoria, Málaga, Spain
🇪🇸
H.G.U. de Elche, Elche, Spain
🇪🇸
Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain

and more 35 locations

Abexinostat in Combination With Pembrolizumab in Patients With Advanced Solid Tumor Malignancies

Phase 1

Completed

Conditions: Stage IV Cutaneous Melanoma
Non-Small Cell Lung Carcinoma
Stage III Cutaneous Melanoma
Metastatic Urothelial Carcinoma
Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage III Lung Cancer AJCC v8
Stage III Ureter Cancer AJCC v8
Stage IIIB Lung Cancer AJCC v8
Stage IV Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8
Stage IV Ureter Cancer AJCC v8

Interventions: Drug: Abexinostat
Biological: Pembrolizumab

First Posted Date: 2018-07-18

Last Posted Date: 2024-03-22

Lead Sponsor: Rahul Aggarwal

Target Recruit Count: 35

Registration Number: NCT03590054

Locations: 🇺🇸
University of California, San Francisco, San Francisco, California, United States

A Safety and Tolerability Study of PCI-24781 in Subjects With Cancer

Phase 1

Completed

Conditions: Lymphoma
Non-Hodgkin's Lymphoma
Hodgkin Disease
Multiple Myeloma
Leukemia
Lymphocytic

Interventions: Drug: PCI-24781

First Posted Date: 2010-06-23

Last Posted Date: 2013-06-19

Lead Sponsor: Pharmacyclics LLC.

Target Recruit Count: 7

Registration Number: NCT01149668

Locations: 🇺🇸
Northwestern Univ. Med School, Chicago, Illinois, United States
🇺🇸
Nebraska Methodist Hospital, Omaha, Nebraska, United States
🇺🇸
Univ. of Nebraska Medical Center, Omaha, Nebraska, United States

and more 2 locations

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