Belinostat

Generic Name: Belinostat

Brand Names: Beleodaq

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₄N_₂O_₄S

CAS Number: 866323-14-0

Unique Ingredient Identifier: F4H96P17NZ

Background: Belinostat is a novel agent that inhibits the enzyme histone deacetylase (HDAC) with a sulfonamide-hydroxamide structure. It was developed as an orphan drug to target hematological malignancies and solid tumors by TopoTarget. The safety and efficacy of belinostat is currently being evaluated for use in combination with traditional front-line therapies for the treatment of PTCL. Intravenous administration of the agent is available as Beleodaq as monotherapy and the dosing regimen involves a 21-day cycle. It was US-approved in July 2014 as a therapeutic agent for relapsed or refractory peripheral T-cell lymphoma.

Indication: Belinostat is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) with manageable safety profile. It is a potential alternative therapy for patients who did not experience adequate response to first-line drugs for PTCL. It can be used in patients with baseline thrombocytopenia .

Associated Conditions: Refractory Peripheral T-Cell Lymphoma, Relapsed Peripheral T-Cell Lymphoma

Clinical Trials

Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics

Phase 1

Recruiting

Conditions: Metastatic Breast Cancer
Recurrent Ovarian Carcinoma

Interventions: Drug: Ribociclib
Drug: Belinostat

First Posted Date: 2020-03-19

Last Posted Date: 2025-04-22

Lead Sponsor: University of Utah

Target Recruit Count: 34

Registration Number: NCT04315233

Locations: 🇺🇸
Huntsman Cancer Institute, Salt Lake City, Utah, United States
🇺🇸
Inova Schar Cancer Institute, Fairfax, Virginia, United States

Extension Study for Patients Who Had Not Met Criteria for Discontinuation in Previous Sponsored Belinostat Trials

Phase 1

Completed

Conditions: Hematological Malignancies
Solid Tumor

Interventions: Drug: Belinostat
Drug: Atazanavir

First Posted Date: 2019-12-04

Last Posted Date: 2023-05-03

Lead Sponsor: Acrotech Biopharma Inc.

Target Recruit Count: 8

Registration Number: NCT04184869

Locations: 🇺🇸
John Wayne Cancer Institute @ Providence Saint John's Health Center, Santa Monica, California, United States

Pevonedistat and Belinostat in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome

Phase 1

Active, not recruiting

Conditions: Refractory Acute Myeloid Leukemia
Recurrent Myelodysplastic Syndrome
Recurrent Acute Myeloid Leukemia
Refractory Myelodysplastic Syndrome

Interventions: Drug: Belinostat
Drug: Pevonedistat

First Posted Date: 2018-12-12

Last Posted Date: 2025-02-14

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 30

Registration Number: NCT03772925

Locations: 🇺🇸
Moffitt Cancer Center-International Plaza, Tampa, Florida, United States
🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States

and more 3 locations

Direct Tumor Microinjection and FDG-PET in Testing Drug Sensitivity in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma, Hodgkin Lymphoma, or Stage IV Breast Cancer

Phase 1

Terminated

Conditions: Metastatic Breast Carcinoma
Recurrent Breast Carcinoma
Recurrent Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Breast Adenocarcinoma
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Refractory Nodal Marginal Zone Lymphoma
Recurrent Mycosis Fungoides
Recurrent Non-Hodgkin Lymphoma
Refractory Non-Hodgkin Lymphoma

Interventions: Drug: Belinostat
Drug: Carfilzomib
Drug: Copanlisib Hydrochloride
Biological: Daratumumab
Drug: Fludeoxyglucose F-18
Drug: Gemcitabine Hydrochloride
Other: Laboratory Biomarker Analysis
Biological: Nivolumab
Biological: Obinutuzumab
Biological: Pembrolizumab
Procedure: Positron Emission Tomography
Biological: Rituximab
Drug: Romidepsin
Other: Saline
Biological: Trastuzumab

First Posted Date: 2018-02-14

Last Posted Date: 2025-05-14

Lead Sponsor: Mayo Clinic

Target Recruit Count: 17

Registration Number: NCT03432741

Locations: 🇺🇸
Mayo Clinic in Rochester, Rochester, Minnesota, United States

Study of Volasertib and Belinostat in Patients With Relapsed and Refractory Aggressive B-cell and T-cell Lymphomas

Phase 1

Withdrawn

Conditions: Relapsed and Refractory Aggressive B- and T-cell Lymphomas
Lymphoma

Interventions: Drug: volasertib
Drug: belinostat

First Posted Date: 2016-08-22

Last Posted Date: 2017-12-22

Lead Sponsor: Yale University

Registration Number: NCT02875002

Locations: 🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Massey Cancer Center, Richmond, Virginia, United States
🇺🇸
Sidney Kimmel Comprehensive Cancer, Baltimore, Maryland, United States

Belinostat Therapy With Zidovudine for Adult T-Cell Leukemia-Lymphoma

Phase 2

Active, not recruiting

Conditions: Adult T-cell Leukemia-Lymphoma
ATLL

Interventions: Drug: Belinostat
Drug: Zidovudine
Drug: Interferon-Alfa-2b
Drug: Pegylated Interferon-Alfa-2b

First Posted Date: 2016-04-13

Last Posted Date: 2025-05-14

Lead Sponsor: University of Miami

Target Recruit Count: 15

Registration Number: NCT02737046

Locations: 🇺🇸
University of Miami, Miami, Florida, United States

Belinostat Combined With Azacitidine/Gemcitabine/Busulfan/Melphalan With Autologous Stem-Cell Transplantation in Refractory or Relapsed Lymphoma

Phase 1

Withdrawn

Conditions: Lymphoma

Interventions: Drug: Busulfan
Drug: Caphosol
Drug: Glutamine
Drug: Pyridoxine
Drug: Belinostat
Drug: Azacitidine
Drug: Gemcitabine
Drug: Melphalan
Procedure: Stem Cell Transplant

First Posted Date: 2016-03-08

Last Posted Date: 2016-05-04

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT02701673

Establish the PK of Belinostat in Patients With Wild-type, Heterozygous, and Homozygous UGT1A1*28 Genotypes

Phase 1

Completed

Conditions: Hematological Malignancies
Solid Tumors

Interventions: Drug: Belinostat IV

First Posted Date: 2016-02-12

Last Posted Date: 2021-09-14

Lead Sponsor: Acrotech Biopharma Inc.

Target Recruit Count: 17

Registration Number: NCT02680795

Locations: 🇺🇸
Gabrail Cancer Center Research, Canton, Ohio, United States
🇺🇸
John Wayne Cancer Institute @ Providence Saint John's Health Center, Santa Monica, California, United States
🇺🇸
The Oncology Institute of Hope and Innovation, Whittier, California, United States

To Evaluate Safety and Pharmacokinetics of Belinostat in Patients Who Have Mild, Moderate and Severe Renal Impairment.

Phase 1

Terminated

Conditions: Relapsed/Refractory Solid Tumors/Hematological Malignancies

Interventions: Drug: Belinostat

First Posted Date: 2016-02-10

Last Posted Date: 2019-11-20

Lead Sponsor: Acrotech Biopharma Inc.

Target Recruit Count: 18

Registration Number: NCT02679131

Locations: 🇺🇸
Innovative Clinical Research Institute, Whittier, California, United States
🇺🇸
Gabrail Cancer Center Research, Canton, Ohio, United States

A Phase Ib Study of Belinostat With RDHAP Chemotherapy (Dexamethasone, Cytarabine, Cisplatinum) in Adults With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Phase 1

Withdrawn

Conditions: Lymphoma

Interventions: Drug: Belinostat
Drug: Rituximab
Drug: Cisplatin
Drug: Cytarabine
Drug: Dexamethasone
Drug: Ciprofloxacin
Drug: Fluconazole

First Posted Date: 2015-08-25

Last Posted Date: 2016-01-06

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT02532192

Drug Development Updates

Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.

Home Terms & Conditions Privacy Policy