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

Belinostat in Treating Patients With Myelodysplastic Syndromes

Phase 2

Completed

Conditions: Previously Treated Myelodysplastic Syndromes
Secondary Myelodysplastic Syndromes
de Novo Myelodysplastic Syndromes

Interventions: Drug: belinostat

First Posted Date: 2006-07-27

Last Posted Date: 2014-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 21

Registration Number: NCT00357162

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

PXD101 in Treating Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Untreated Adult Acute Myeloid Leukemia

Interventions: Drug: belinostat
Other: laboratory biomarker analysis

First Posted Date: 2006-07-27

Last Posted Date: 2018-04-17

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 12

Registration Number: NCT00357032

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

PXD101 and 17-N-Allylamino-17-Demethoxygeldanamycin in Treating Patients With Metastatic or Unresectable Solid Tumors or Lymphoma

Phase 1

Terminated

Conditions: Adult Nasal Type Extranodal NK/T-cell Lymphoma
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Intraocular Lymphoma
Nodal Marginal Zone B-cell Lymphoma
Post-transplant Lymphoproliferative Disorder
Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma
Recurrent Adult Diffuse Mixed Cell Lymphoma

Interventions: Drug: tanespimycin
Drug: belinostat
Other: laboratory biomarker analysis
Other: pharmacological study

First Posted Date: 2006-07-20

Last Posted Date: 2013-05-16

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 36

Registration Number: NCT00354185

Locations: 🇺🇸
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

Belinostat and Azacitidine in Treating Patients With Advanced Hematologic Cancers or Other Diseases

Phase 1

Completed

Conditions: Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Accelerated Phase of Disease
Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA
de Novo Myelodysplastic Syndrome
Primary Myelofibrosis
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL
Atypical Chronic Myeloid Leukemia, BCR-ABL1 Negative
Chronic Myelogenous Leukemia, BCR-ABL1 Positive

Interventions: Drug: Belinostat
Drug: Azacitidine
Other: Laboratory Biomarker Analysis

First Posted Date: 2006-07-14

Last Posted Date: 2014-12-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 56

Registration Number: NCT00351975

Locations: 🇳🇿
Princess Margaret Hospital, Cashmere, Canterbury, New Zealand
🇨🇦
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada
🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States

and more 1 locations

PXD101 and Bortezomib in Treating Patients With Advanced Solid Tumors or Lymphomas

Phase 1

Completed

Conditions: Recurrent Adult Diffuse Mixed Cell Lymphoma
Stage III Adult Burkitt Lymphoma
Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
Nodal Marginal Zone B-cell Lymphoma
Primary Central Nervous System Non-Hodgkin Lymphoma
Recurrent Adult Diffuse Small Cleaved Cell Lymphoma
Recurrent Adult Grade III Lymphomatoid Granulomatosis
Angioimmunoblastic T-cell Lymphoma
Recurrent Adult Immunoblastic Large Cell Lymphoma
Recurrent Adult Lymphoblastic Lymphoma

Interventions: Drug: belinostat
Drug: bortezomib
Other: pharmacological study

First Posted Date: 2006-07-06

Last Posted Date: 2013-05-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 55

Registration Number: NCT00348985

Locations: 🇺🇸
University of Colorado, Denver, Colorado, United States

Belinostat and Isotretinoin in Treating Patients With Solid Tumors That Are Metastatic or That Cannot Be Removed by Surgery

Phase 1

Completed

Conditions: Adult Solid Neoplasm

Interventions: Drug: Belinostat
Drug: Isotretinoin
Other: Pharmacological Study

First Posted Date: 2006-06-08

Last Posted Date: 2018-04-03

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 51

Registration Number: NCT00334789

Locations: 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸
University of Pittsburgh Cancer Institute (UPCI), Pittsburgh, Pennsylvania, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 2 locations

Belinostat in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

Phase 1

Completed

Conditions: Adult Primary Hepatocellular Carcinoma
Advanced Adult Primary Liver Cancer
Localized Unresectable Adult Primary Liver Cancer
Recurrent Adult Primary Liver Cancer

Interventions: Drug: belinostat

First Posted Date: 2006-05-04

Last Posted Date: 2017-11-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 54

Registration Number: NCT00321594

Locations: 🇸🇬
Cancer Therapeutics Research Group, Singapore, Singapore
🇺🇸
University of Wisconsin Hospital and Clinics, Madison, Wisconsin, United States

PXD101 in Treating Patients With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Phase 2

Completed

Conditions: Recurrent Adult Burkitt Lymphoma
Recurrent Adult Diffuse Large Cell Lymphoma

Interventions: Drug: belinostat

First Posted Date: 2006-03-17

Last Posted Date: 2014-05-12

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 22

Registration Number: NCT00303953

Locations: 🇺🇸
Heartland Regional Medical Center, Saint Joseph, Missouri, United States
🇺🇸
Kalispell Medical Oncology, Kalispell, Montana, United States
🇺🇸
Kalispell Regional Medical Center, Kalispell, Montana, United States

and more 120 locations

Belinostat in Treating Patients With Advanced Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer or Ovarian Low Malignant Potential Tumors

Phase 2

Completed

Conditions: Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor
Stage IV Borderline Ovarian Surface Epithelial-Stromal Tumor
Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor
Stage IV Ovarian Cancer
Fallopian Tube Carcinoma
Primary Peritoneal Carcinoma
Recurrent Ovarian Carcinoma
Stage III Ovarian Cancer

Interventions: Drug: Belinostat
Other: Laboratory Biomarker Analysis

First Posted Date: 2006-03-13

Last Posted Date: 2018-08-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 32

Registration Number: NCT00301756

Locations: 🇨🇦
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
🇨🇦
Odette Cancer Centre- Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
🇨🇦
University Health Network-Princess Margaret Hospital, Toronto, Ontario, Canada

and more 1 locations

A Phase II Clinical Trial of PXD101 in Patients With Recurrent or Refractory Cutaneous and Peripheral T-Cell Lymphomas

Phase 2

Terminated

Conditions: Cutaneous T-Cell Lymphoma
Peripheral T-Cell Lymphoma
Non-Hodgkin's Lymphoma

Interventions: Drug: belinostat

First Posted Date: 2006-01-11

Last Posted Date: 2015-07-28

Lead Sponsor: Valerio Therapeutics

Target Recruit Count: 53

Registration Number: NCT00274651

Locations: 🇺🇸
Leland Stanford Junior University, Stanford, California, United States
🇺🇸
NYU Medical Center, New York, New York, United States
🇺🇸
Cleveland Clinic Foundation, Cleveland, Ohio, United States

and more 12 locations

Drug Development Updates

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