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

Phase I Trial of AZD1775 and Belinostat in Treating Patients With Relapsed or Refractory Myeloid Malignancies or Untreated Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Acute Myeloid Leukemia
Previously Treated Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Blast Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Refractory Chronic Myelogenous Leukemia, BCR-ABL1 Positive
Secondary Acute Myeloid Leukemia
Therapy-Related Acute Myeloid Leukemia
Myelodysplastic Syndrome
Untreated Adult Acute Myeloid Leukemia
Recurrent Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions: Drug: Adavosertib
Drug: Belinostat
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2015-03-06

Last Posted Date: 2018-05-25

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 20

Registration Number: NCT02381548

Locations: 🇺🇸
Moffitt Cancer Center, Tampa, Florida, United States
🇺🇸
Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia, United States

Carfilzomib Plus Belinostat in Relapsed/Refractory NHL

Phase 1

Completed

Conditions: Non-Hodgkin Lymphoma
Peripheral T-cell Lymphoma
Follicular Lymphoma
Diffuse Large B-cell Lymphoma
Mantle Cell Lymphoma

Interventions: Drug: Carfilzomib
Drug: Belinostat

First Posted Date: 2014-05-20

Last Posted Date: 2018-01-25

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 19

Registration Number: NCT02142530

Locations: 🇺🇸
Massachusetts General Hospital, Boston, Massachusetts, United States
🇺🇸
Dana Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Beth-Israel Deaconess Medical Center, Boston, Massachusetts, United States

MRSI to Predict Response to RT/TMZ ± Belinostat in GBM

Phase 2

Active, not recruiting

Conditions: Glioblastoma Multiforme of Brain

Interventions: Radiation: Standard Radiation Therapy
Drug: Standard Temozolomide
Drug: Belinostat

First Posted Date: 2014-05-14

Last Posted Date: 2023-05-06

Lead Sponsor: Emory University

Target Recruit Count: 29

Registration Number: NCT02137759

Locations: 🇺🇸
Emory University/Winship Cancer Institute, Atlanta, Georgia, United States
🇺🇸
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Phase 1 Dose Finding Study of Belinostat for Treatment of Patients With Peripheral T-cell Lymphoma (PTCL)

Phase 1

Completed

Conditions: Peripheral T-cell Lymphoma

Interventions: Drug: Belinostat
Drug: CHOP

First Posted Date: 2013-04-24

Last Posted Date: 2020-01-03

Lead Sponsor: Acrotech Biopharma Inc.

Target Recruit Count: 23

Registration Number: NCT01839097

Locations: 🇺🇸
Hematology - Oncology Associates of Northern NJ P.A, Morristown, New Jersey, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States
🇺🇸
John Theurer Cancer Center at Hackensack University Medical Center, Hackensack, New Jersey, United States

and more 5 locations

Belinostat and Yttrium Y 90 Ibritumomab Tiuxetan in Patients W/Relapsed Aggressive B-Cell NHL

Phase 2

Completed

Conditions: Anaplastic Large Cell Lymphoma
Recurrent Mantle Cell Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma

Interventions: Drug: belinostat
Biological: rituximab
Radiation: yttrium Y 90 ibritumomab tiuxetan

First Posted Date: 2012-09-17

Last Posted Date: 2018-08-28

Lead Sponsor: University of Arizona

Target Recruit Count: 5

Registration Number: NCT01686165

Locations: 🇺🇸
University of Arizona Cancer Center, Tucson, Arizona, United States

Phase I Mass Balance, PK and Safety Study of 14C-Labeled Belinostat in Patients With Advanced Cancer

Phase 1

Completed

Conditions: Advanced Cancer

Interventions: Drug: Belinostat

First Posted Date: 2012-04-24

Last Posted Date: 2020-01-03

Lead Sponsor: Acrotech Biopharma Inc.

Target Recruit Count: 6

Registration Number: NCT01583777

Locations: 🇪🇸
Hospital Universitario Madrid Sanchinarro, Madrid, Spain

Belinostat for Solid Tumors and Lymphomas in Patients With Varying Degrees of Hepatic Dysfunction

Phase 1

Completed

Conditions: Lymphomas
Neoplasms

Interventions: Drug: Belinostat

First Posted Date: 2011-01-10

Last Posted Date: 2019-03-26

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 72

Registration Number: NCT01273155

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States
🇺🇸
USC Norris Cancer Center, Los Angeles, California, United States
🇺🇸
University of California, Davis, Davis, California, United States

and more 4 locations

A Trial of Belinostat in Combination With Erlotinib in Patients With Non-small Cell Lung Cancer

Phase 1

Terminated

Conditions: Non Small Cell Lung Cancer

Interventions: Drug: Belinostat and Erlotinib

First Posted Date: 2010-08-25

Last Posted Date: 2020-10-19

Lead Sponsor: Herlev Hospital

Target Recruit Count: 5

Registration Number: NCT01188707

Locations: 🇩🇰
Dept of Oncology Copenhagen University Hospital Herlev, Copenhagen, Denmark

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

Phase 1

Completed

Conditions: Acute Lymphocytic Leukemia
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Chronic Myelogenous Leukemia

Interventions: Drug: bortezomib
Drug: belinostat
Other: laboratory biomarker analysis
Genetic: western blotting
Other: pharmacological study
Other: flow cytometry

First Posted Date: 2010-02-25

Last Posted Date: 2016-04-15

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 41

Registration Number: NCT01075425

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

Belinostat and Carboplatin in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer That Did Not Respond to Carboplatin or Cisplatin

Phase 2

Completed

Conditions: Fallopian Tube Cancer
Ovarian Clear Cell Cystadenocarcinoma
Ovarian Serous Cystadenocarcinoma
Ovarian Undifferentiated Adenocarcinoma
Brenner Tumor
Ovarian Endometrioid Adenocarcinoma
Ovarian Mucinous Cystadenocarcinoma
Primary Peritoneal Cavity Cancer
Recurrent Ovarian Epithelial Cancer
Ovarian Mixed Epithelial Carcinoma

Interventions: Drug: belinostat
Drug: carboplatin

First Posted Date: 2009-10-12

Last Posted Date: 2019-07-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 29

Registration Number: NCT00993616

Locations: 🇺🇸
Green Bay Oncology - Oconto Falls, Oconto Falls, Wisconsin, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇺🇸
Women's Cancer Center of Nevada, Las Vegas, Nevada, United States

and more 78 locations

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