Pracinostat

Generic Name: Pracinostat

Brand Names: -

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₃₀N_₄O_₂

CAS Number: 929016-96-6

Unique Ingredient Identifier: GPO2JN4UON

Background: Pracinostat is a novel HDAC inhibitor with improved in vivo properties compared to other HDAC inhibitors currently in clinical trials, allowing oral dosing. Data demonstrate that Pracinostat is a potent and effective anti-tumor drug with potential as an oral therapy for a variety of human hematological and solid tumors.

Indication: For the treatment of various forms of cancer.

Associated Conditions: -

Associated Therapies: -

Clinical Trials

A Study In Healthy Male Volunteers Designed To Investigate How A Radiolabelled Medicine Is Broken Down And Removed From The Body

Phase 1

Completed

Conditions: Healthy Subjects

Interventions: Drug: pracinostat

First Posted Date: 2018-04-12

Last Posted Date: 2019-08-08

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 6

Registration Number: NCT03495934

Locations: 🇬🇧
Quotient Science, Ruddington, United Kingdom

A Safety and Efficacy Study of Pracinostat and Azacitidine in Patients With High Risk Myelodysplastic Syndromes

Phase 2

Terminated

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Pracinostat
Drug: Azacitidine

First Posted Date: 2017-05-12

Last Posted Date: 2022-03-02

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 64

Registration Number: NCT03151304

Locations: 🇺🇸
University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States
🇺🇸
Scripps Cancer Center-Mercy, San Diego, California, United States
🇺🇸
Swedish Cancer Institute, Seattle, Washington, United States

and more 22 locations

An Efficacy and Safety Study Of Pracinostat In Combination With Azacitidine In Adults With Acute Myeloid Leukemia

Phase 3

Terminated

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Placebos
Drug: Pracinostat
Drug: Azacitidine

First Posted Date: 2017-05-12

Last Posted Date: 2022-03-10

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 406

Registration Number: NCT03151408

Locations: 🇷🇴
clinical hospital Coltea Bld, Bucuresti, Romania
🇺🇸
University Hospital Cleveland Medical Center, Cleveland, Ohio, United States
🇨🇳
Hematology and Oncology, Changhwa Christian Hospital, Changhua, Taiwan

and more 135 locations

Ruxolitinib and Pracinostat Combination Therapy for Patients With Myelofibrosis (MF)

Phase 2

Completed

Conditions: Myeloproliferative Diseases

Interventions: Drug: Ruxolitinib
Drug: Pracinostat
Behavioral: Questionnaire

First Posted Date: 2014-10-17

Last Posted Date: 2019-06-12

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 25

Registration Number: NCT02267278

Locations: 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Evaluate the Effects of Itraconazole and Ciprofloxacin on Single-Dose PK of Pracinostat in Healthy Nonsmoking Subjects

Phase 1

Completed

Conditions: Non-smokers
Healthy Volunteers

Interventions: Drug: Pracinostat
Drug: Itraconazole
Drug: Ciprofloxacin

First Posted Date: 2014-04-21

Last Posted Date: 2017-02-23

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 32

Registration Number: NCT02118909

Locations: 🇺🇸
Celerion, Tempe, Arizona, United States

Study to Evaluate the Food Effect of Single-dose Bioavailability of Pracinostat in Healthy Adult Subjects

Early Phase 1

Completed

Conditions: Healthy Volunteers
Moderate to Heavy Smokers
Non-smokers

Interventions: Drug: pracinostat

First Posted Date: 2014-02-10

Last Posted Date: 2017-02-23

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 28

Registration Number: NCT02058784

Locations: 🇺🇸
Celerion, Tempe, Arizona, United States

Phase 2 Study Adding Pracinostat to a Hypomethylating Agent (HMA) in Patients With MDS Who Failed to Respond to Single Agent HMA

Phase 2

Completed

Conditions: Myelodysplastic Syndrome
MDS

Interventions: Drug: pracinostat
Drug: Azacitidine
Drug: Decitabine

First Posted Date: 2013-11-25

Last Posted Date: 2017-02-23

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 45

Registration Number: NCT01993641

Locations: 🇺🇸
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
🇺🇸
Northwestern University, Chicago, Illinois, United States
🇺🇸
MD Anderson Cancer Center, Houston, Texas, United States

and more 18 locations

Safety and Efficacy Study of Pracinostat With Azacitadine in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Pracinostat
Drug: Azacitidine

First Posted Date: 2013-07-31

Last Posted Date: 2021-02-09

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 50

Registration Number: NCT01912274

Locations: 🇺🇸
The University of Chicago, Chicago, Illinois, United States
🇺🇸
MD Anderson, Houston, Texas, United States
🇺🇸
University of Kansas Cancer Center, Westwood, Kansas, United States

and more 14 locations

Phase 2 Study of Pracinostat With Azacitidine in Patients With Previously Untreated Myelodysplastic Syndrome

Phase 2

Completed

Conditions: Myelodysplastic Syndrome

Interventions: Drug: pracinostat
Drug: Placebo
Drug: Azacitidine

First Posted Date: 2013-06-10

Last Posted Date: 2018-09-13

Lead Sponsor: Helsinn Healthcare SA

Target Recruit Count: 102

Registration Number: NCT01873703

Locations: 🇺🇸
Woodlands Medical Specialists, Pensacola, Florida, United States
🇺🇸
Weill Cornell Medical Center, New York, New York, United States
🇺🇸
Florida Cancer Specialists North, Saint Petersburg, Florida, United States

and more 21 locations

Drug Development Updates

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