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

A Phase I Study of Belinostat in Combination With Cisplatin and Etoposide in Adults With Small Cell Lung Carcinoma and Other Advanced Cancers

Phase 1

Completed

Conditions: Carcinoma Neuroendocrine
Small Cell Lung Carcinoma
Malignant Epithelial Neoplasms

Interventions: Drug: Belinostat
Drug: Cisplatin
Drug: Etoposide

First Posted Date: 2009-06-23

Last Posted Date: 2018-10-19

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 28

Registration Number: NCT00926640

Locations: 🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Phase I/II Clinical Trial of PXD101 in Combination With Doxorubicin in Patients With Soft Tissue Sarcomas

Phase 1

Completed

Conditions: Dose Escalation: Solid Tumors
MTD: Soft Tissue Sarcomas

Interventions: Drug: PXD101
Drug: Doxorubicin

First Posted Date: 2009-04-09

Last Posted Date: 2015-07-28

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 41

Registration Number: NCT00878800

Locations: 🇬🇧
The Royal Marsden NHS Trust, Cancer Research, Surrey, United Kingdom
🇩🇰
Herlev Hospital, Department of Oncology, Herlev, Denmark
🇩🇰
Århus Hospital, Department of Oncology, Århus, Denmark

Trial of PXD101 (Belinostat) in Combination With Idarubicin to Treat AML Not Suitable for Standard Intensive Therapy

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: PXD101
Drug: idarubicin

First Posted Date: 2009-04-09

Last Posted Date: 2015-07-28

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 41

Registration Number: NCT00878722

Locations: 🇫🇷
Hôpital St. Louis, Paris, France
🇩🇪
Uniklinik Homburg, Homburg, Germany
🇩🇪
Uni Hospital Marburg, Marburg, Germany

and more 3 locations

Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma

Phase 2

Completed

Conditions: Peripheral T-cell Lymphoma

Interventions: Drug: Belinostat

First Posted Date: 2009-03-20

Last Posted Date: 2021-10-29

Lead Sponsor: Spectrum Pharmaceuticals, Inc

Target Recruit Count: 129

Registration Number: NCT00865969

Locations: 🇺🇸
New York University, New York, New York, United States
🇺🇸
Upstate Medical Univeristy Syracuse, Syracuse, New York, United States
🇺🇸
Rush University Medical Center, Chicago, Illinois, United States

and more 114 locations

Belinostat (PXD101) to Treat Tumors of the Thymus at an Advanced Stage

Phase 2

Completed

Conditions: Thymic Carcinoma
Thymoma

Interventions: Drug: Belinostat (PDX101)

First Posted Date: 2008-01-09

Last Posted Date: 2015-09-30

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 41

Registration Number: NCT00589290

Locations: 🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States
🇺🇸
National Institutes of Health Clinical Center, 9000 Rockville Pike, Bethesda, Maryland, United States

A Phase II Study of Belinostat in Combination With Bortezomib in Patients With Relapsed, Refractory Multiple Myeloma

Phase 2

Terminated

Conditions: Multiple Myeloma

First Posted Date: 2007-02-05

Last Posted Date: 2015-07-08

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 4

Registration Number: NCT00431340

Locations: 🇺🇸
Oncotherapeutics, West Hollywood, California, United States
🇺🇸
Center for cancer and blood disorders, Bethesda, Maryland, United States
🇺🇸
Baylor University Medical Center, Dallas, Texas, United States

A Study of Belinostat + Carboplatin or Paclitaxel or Both in Patients With Ovarian Cancer in Need of Relapse Treatment

Phase 1

Completed

Conditions: Ovarian Cancer
Epithelial Ovarian Cancer
Bladder Cancer
Fallopian Tube Cancer

Interventions: Drug: belinostat
Drug: Paclitaxel
Drug: Carboplatin

First Posted Date: 2007-01-15

Last Posted Date: 2015-07-28

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 80

Registration Number: NCT00421889

Locations: 🇺🇸
Greater Baltimore Medical Center, Baltimore, Maryland, United States
🇺🇸
Hematology & Oncology Specialists, LLC, Metairie, Louisiana, United States
🇬🇧
The Royal Marsden NHS Trust, Surrey, United Kingdom

and more 8 locations

Study of Oral PXD101 in Patients With Advanced Solid Tumors or Lymphoma

Phase 1

Completed

Conditions: Lymphoma
Solid Tumor

Interventions: Drug: oral belinostat

First Posted Date: 2006-12-19

Last Posted Date: 2015-07-08

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 121

Registration Number: NCT00413075

Locations: 🇺🇸
New York University Cancer Institute, New York, New York, United States
🇺🇸
Yale New Haven Hospital, New Haven, Connecticut, United States
🇬🇧
Research Facility, London, Surrey, United Kingdom

and more 2 locations

Study of PXD101 Alone and in Combination With 5-Fluorouracil (5-FU) in Patients With Advanced Solid Tumors

Phase 1

Completed

Conditions: Tumor

Interventions: Drug: belinostat
Drug: 5-Fluorouracil (5-FU)

First Posted Date: 2006-12-19

Last Posted Date: 2015-07-08

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 35

Registration Number: NCT00413322

Locations: 🇺🇸
Mayo Clinic Arizona, Scottsdale, Arizona, United States
🇺🇸
Portsmouth Regional Hospital Hematology/Oncology Clinic, Portsmouth, New Hampshire, United States
🇺🇸
University of Nebraska, Omaha, Nebraska, United States

PXD101 as Second-Line Therapy in Treating Patients With Malignant Mesothelioma of the Chest That Cannot Be Removed By Surgery

Phase 2

Completed

Conditions: Epithelial Mesothelioma
Sarcomatous Mesothelioma
Recurrent Malignant Mesothelioma
Advanced Malignant Mesothelioma

Interventions: Drug: belinostat
Other: laboratory biomarker analysis

First Posted Date: 2006-08-17

Last Posted Date: 2018-06-07

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT00365053

Locations: 🇺🇸
City of Hope, Duarte, California, United States

Drug Development Updates

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