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Belinostat

Generic Name
Belinostat
Brand Names
Beleodaq
Drug Type
Small Molecule
Chemical Formula
C15H14N2O4S
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
Related News

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Phase 3
Recruiting
Conditions
Systemic Anaplastic Large Cell Lymphoma
Peripheral T-Cell Lymphoma, Not Otherwise Specified
Angioimmunoblastic T-cell Lymphoma
Lymphoma, T-Cell, Peripheral
Follicular T-Cell Lymphoma
Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
Lymphoma, T-Cell
Interventions
First Posted Date
2024-08-19
Last Posted Date
2025-04-17
Lead Sponsor
Corvus Pharmaceuticals, Inc.
Target Recruit Count
150
Registration Number
NCT06561048
Locations
🇺🇸

Corvus Pharmaceuticals, South San Francisco, California, United States

A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity

Phase 2
Recruiting
Conditions
Carcinoma, Neuroendocrine
Tumor, Neuroendocrine
Tumors, Neuroendocrine
Neuroendocrine; Carcinoma
Small Cell; Receptors
Interventions
First Posted Date
2024-05-09
Last Posted Date
2025-05-21
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
60
Registration Number
NCT06406465
Locations
🇺🇸

National Institutes of Health Clinical Center, Bethesda, Maryland, United States

To Evaluate Efficacy of Belinostat or Pralatrexate in Combination Against CHOP Alone in PTCL

Phase 3
Recruiting
Conditions
Peripheral T Cell Lymphoma
Interventions
Drug: CHOP
First Posted Date
2023-10-10
Last Posted Date
2025-05-16
Lead Sponsor
Acrotech Biopharma Inc.
Target Recruit Count
504
Registration Number
NCT06072131
Locations
🇺🇸

University of California, San Francisco Fresno, Clovis, California, United States

🇺🇸

University of California, Los Angeles Hem/ Onc Clinical Research Unit, Suite 600, Santa Monica, California, United States

🇺🇸

Moffitt Malignant Hematology & Cellular Therapy at Memorial Healthcare System Memorial Cancer Institute, Pembroke Pines, Florida, United States

and more 49 locations

Testing the Safety of the Anti-cancer Drugs Tazemetostat and Belinostat in Patients With Lymphomas That Have Resisted Treatment

Phase 1
Recruiting
Conditions
Recurrent B-Cell Non-Hodgkin Lymphoma
Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
Recurrent Follicular Lymphoma
Recurrent Non-Hodgkin Lymphoma
Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma
Recurrent T-Cell Non-Hodgkin Lymphoma
Recurrent Transformed Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma
Refractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
Refractory Follicular Lymphoma
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Other: Pharmacokinetic Study
Procedure: Positron Emission Tomography and Computed Tomography Scan
First Posted Date
2022-11-25
Last Posted Date
2025-05-20
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
48
Registration Number
NCT05627245
Locations
🇺🇸

University of California Davis Comprehensive Cancer Center, Sacramento, California, United States

🇺🇸

Yale University, New Haven, Connecticut, United States

🇺🇸

University of Kansas Clinical Research Center, Fairway, Kansas, United States

and more 7 locations

Binimetinib Plus Belinostat for Subjects With Metastatic Uveal Melanoma

Phase 2
Recruiting
Conditions
Metastatic Uveal Melanoma
Interventions
First Posted Date
2021-12-27
Last Posted Date
2025-03-13
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Target Recruit Count
32
Registration Number
NCT05170334
Locations
🇺🇸

Moffitt Cancer Center, Tampa, Florida, United States

Tremelimumab + Durvalumab(MEDI4736)+ Belinostat in Urothelial Carcinoma

Phase 1
Recruiting
Conditions
Infiltrating Urothelial Carcinoma, Sarcomatoid Variant
Locally Advanced Urothelial Carcinoma
Metastatic Urothelial Carcinoma
Unresectable Urothelial Carcinoma
Interventions
First Posted Date
2021-12-13
Last Posted Date
2025-04-24
Lead Sponsor
University of Utah
Target Recruit Count
9
Registration Number
NCT05154994
Locations
🇺🇸

Huntsman Cancer Institute/University of Utah, Salt Lake City, Utah, United States

Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL

First Posted Date
2021-02-10
Last Posted Date
2024-08-07
Lead Sponsor
University of Virginia
Target Recruit Count
50
Registration Number
NCT04747236
Locations
🇺🇸

Duke University, Durham, North Carolina, United States

🇺🇸

Icahn School of Medicine at Mount Sinai, New York, New York, United States

🇺🇸

University of Virginia, Charlottesville, Virginia, United States

and more 2 locations

Talazoparib in Combination With Belinostat for Metastatic Breast Cancer, Metastatic Castration Resistant Prostate Cancer, and Metastatic Ovarian Cancer

Phase 1
Completed
Conditions
Metastatic Breast Cancer
Metastatic Castration-resistant Prostate Cancer
Metastatic Ovarian Carcinoma
Metastic or Unresectable Pancreatic Adenocarcinoma
Interventions
First Posted Date
2021-01-11
Last Posted Date
2025-01-23
Lead Sponsor
University of Michigan Rogel Cancer Center
Target Recruit Count
26
Registration Number
NCT04703920
Locations
🇺🇸

University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

Testing the Combination of Belinostat and SGI-110 (Guadecitabine) or ASTX727 for the Treatment of Unresectable and Metastatic Conventional Chondrosarcoma

Phase 2
Active, not recruiting
Conditions
Metastatic Primary Central Chondrosarcoma
Locally Advanced Unresectable Primary Central Chondrosarcoma
Unresectable Primary Central Chondrosarcoma
Interventions
Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
First Posted Date
2020-04-10
Last Posted Date
2025-05-18
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
20
Registration Number
NCT04340843
Locations
🇺🇸

Salina Regional Health Center, Salina, Kansas, United States

🇺🇸

University of Kansas Health System Saint Francis Campus, Topeka, Kansas, United States

🇺🇸

Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States

and more 36 locations

Evaluating Safety & Efficacy Belinostat Combo w Nivo Alone & w Ipi in Patients w Treated Metastatic/Advanced Carcinomas w ARID1A Lof Mutation

Phase 1
Withdrawn
Conditions
Metastatic Adenocarcinoma
Interventions
First Posted Date
2020-03-19
Last Posted Date
2020-10-28
Lead Sponsor
University of Utah
Registration Number
NCT04315155
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