Pracinostat

DRUG9 trials

Conditions

Acute Myeloid LeukemiaHealthy SubjectsHealthy VolunteersMDSModerate to Heavy SmokersMyelodysplastic SyndromeMyelodysplastic SyndromesMyeloproliferative Diseases

Early Phase 1

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

CompletedNCT02058784

Helsinn Healthcare SAHealthy Volunteers, Moderate to Heavy Smokers, Non-smokers

Start: 2014-02-28End: 2014-03-31Updated: 2017-02-23

Phase 1

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

CompletedNCT02118909

Helsinn Healthcare SAHealthy Volunteers, Non-smokers

Start: 2014-05-31End: 2014-08-31Updated: 2017-02-23

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

CompletedNCT03495934

Helsinn Healthcare SAHealthy Subjects

Start: 2018-02-08End: 2018-02-28Updated: 2019-08-08

Phase 2

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

CompletedNCT01873703

Helsinn Healthcare SAMyelodysplastic Syndrome

Start: 2013-06-30End: 2016-11-30Updated: 2018-09-13

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

CompletedNCT01912274

Helsinn Healthcare SAAcute Myeloid Leukemia

Start: 2013-12-24End: 2016-11-08Updated: 2021-02-09

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

CompletedNCT01993641

Helsinn Healthcare SAMDS, Myelodysplastic Syndrome

Start: 2013-12-31End: 2016-06-30Updated: 2017-02-23

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

CompletedNCT02267278

M.D. Anderson Cancer CenterMyeloproliferative Diseases

Start: 2015-01-12End: 2018-06-01Updated: 2019-06-12

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

TerminatedNCT03151304

Helsinn Healthcare SAMyelodysplastic Syndromes

Start: 2017-06-01End: 2020-12-01Updated: 2022-03-02

Phase 3

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

TerminatedNCT03151408

Helsinn Healthcare SAAcute Myeloid Leukemia

Start: 2017-06-23End: 2020-08-20Updated: 2022-03-10

2024-03-129 citations

Phase II study of lower-dose pracinostat plus azacitidine safety and efficacy in patients with high/very high-risk myelodysplastic syndromes.

Journal of Clinical Oncology2020-05-206 citations

Abstract B009: The histone deacetylase inhibitor pracinostat and its metabolite SB991 are active as single agents and in combination with 5-azacitidine in acute myeloid leukemia cells

Molecular Cancer Therapeutics2019-12-01

A Phase 3 Randomized Study (PRIMULA) of the Epigenetic Combination of Pracinostat, a Pan-Histone Deacetylase (HDAC) Inhibitor, with Azacitidine (AZA) in Patients with Newly Diagnosed Acute Myeloid Leukemia (AML) Unfit for Standard Intensive Chemotherapy (IC)

Blood2019-11-135 citations

Abstract 4735: The histone deacetylase inhibitor pracinostat modulates the transcriptome of diffuse large B-cell lymphoma cells and is active in combination with several targeted agents

Experimental and Molecular Therapeutics2019-07-01

Abstract 4735: The histone deacetylase inhibitor pracinostat modulates the transcriptome of diffuse large B-cell lymphoma cells and is active in combination with several targeted agents

Cancer Research2019-07-01

PB1746 PRACINOSTAT PLUS AZACITIDINE IN OLDER PATIENTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA (AML): A CASE REPORT FROM A PHASE 2 STUDY

HemaSphere2019-06-012 citations

Pracinostat plus azacitidine in older patients with newly diagnosed acute myeloid leukemia: results of a phase 2 study

Blood Advances2019-02-1386 citations

Abstract 799: The novel histone deacetylase inhibitor pracinostat is an effective anti-lymphoma agent

Cancer Research2018-07-01

A phase 3, randomized study of pracinostat (PRAN) in combination with azacitidine (AZA) versus placebo in patients ≥18 years with newly diagnosed acute myeloid leukemia (AML) unfit for standard induction chemotherapy (IC).

Journal of Clinical Oncology2018-05-203 citations

Correlation between mutation clearance and clinical response in elderly patients with acute myeloid leukemia (AML) treated with azacitidine and pracinostat.

Journal of Clinical Oncology2017-05-204 citations

A Phase 2 Study of Pracinostat and Azacitidine in Elderly Patients with Acute Myeloid Leukemia (AML) Not Eligible for Induction Chemotherapy: Response and Long-Term Survival Benefit

Blood2016-12-0220 citations