Azacitidine

Generic Name: Azacitidine

Brand Names: Onureg, Vidaza, Azacitidine Accord, Azacitidine betapharm, Azacitidine Mylan, Azacitidine Kabi

Drug Type: Small Molecule

Chemical Formula: C_₈H_₁₂N_₄O_₅

CAS Number: 320-67-2

Unique Ingredient Identifier: M801H13NRU

Background: Azacitidine is a pyrimidine nucleoside analogue with anti-neoplastic activity. It differs from cytosine by the presence of nitrogen in the C5-position, key in its hypomethylating activity. Two main mechanisms of action have been proposed for azacitidine. One of them is the induction of cytotoxicity. As an analogue of cytidine, it is able to incorporate into ...

Indication: Azacitidine (for subcutaneous or intravenous use) is indicated for the treatment of adult patients with the following French-American-British (FAB) myelodysplastic syndrome (MDS) subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemi...

Associated Conditions: Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Refractory Anemia, Refractory Anemia With Excess Blasts in Transformation, Refractory Anemia With Excess of Blasts (RAEB), Refractory Anemia With Ringed Sideroblasts, Newly diagnosed Juvenile Myelomonocytic Leukaemias (JMML)

Associated Therapies: -

Clinical Trials

Combination of 5-azacitidine and Lenalidomide in Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML) Myelodysplastic Syndromes

Phase 1

Terminated

Conditions: Myelodysplastic Syndromes
Acute Myelogenous Leukemia

Interventions: Drug: Azacitidine
Drug: Lenalidomide

First Posted Date: 2009-06-18

Last Posted Date: 2013-12-18

Lead Sponsor: Technische Universität Dresden

Registration Number: NCT00923234

Locations: 🇩🇪
Technische Universität München, Klinikum Rechts der Isar, München, Germany
🇩🇪
Medizinische Klinik und Poliklinik I, Uniklinik, Dresden, Germany
🇩🇪
Universitätsklinikum Düsseldorf, Klinik für Hämatologie/Onkologie/klinische Immunologie, Düsseldorf, Germany

and more 1 locations

Efficacy of 5-azacytidine Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: azacitidine

First Posted Date: 2009-06-05

Last Posted Date: 2012-12-17

Lead Sponsor: University Hospital Muenster

Target Recruit Count: 214

Registration Number: NCT00915252

Locations: 🇩🇪
RWTH Aachen, Medizinische Klinik IV, Aachen, Germany
🇩🇪
Universitätsklinikum Erlangen, Medizinische Klinik 5, Erlangen, Germany
🇩🇪
Universitätsklinikum Essen, Klinik für Hämatologie, Essen, Germany

and more 24 locations

MLN4924 for the Treatment of Acute Myelogenous Leukemia, Myelodysplastic Syndrome, and Acute Lymphoblastic Leukemia

Phase 1

Completed

Conditions: Myelodysplastic Syndrome
Acute Myelogenous Leukemia
Acute Lymphoblastic Leukemia

Interventions: Drug: MLN4924
Drug: Azacitidine

First Posted Date: 2009-06-01

Last Posted Date: 2013-12-05

Lead Sponsor: Millennium Pharmaceuticals, Inc.

Target Recruit Count: 72

Registration Number: NCT00911066

Locations: 🇺🇸
University of Michigan Comprehensive Cancer Center, Ann Arbor, Michigan, United States
🇺🇸
Johns Hopkins Kimmel Cancer Center, Baltimore, Maryland, United States
🇺🇸
Stanford University Medical Center, Stanford, California, United States

and more 3 locations

5-Azacitidine in Low-risk Myelodysplastic Syndromes (MDSs)

Phase 2

Completed

Conditions: Myelodysplastic Syndrome

Interventions: Drug: Azacytidine

First Posted Date: 2009-05-12

Last Posted Date: 2014-12-03

Lead Sponsor: Università degli Studi di Brescia

Target Recruit Count: 28

Registration Number: NCT00897130

Locations: 🇮🇹
University of Siena, Siena, Italy
🇮🇹
University of Bologna, Bologna, Italy
🇮🇹
University of Udine, Udine, Italy

and more 4 locations

Vorinostat, Azacitidine, and Gemtuzumab Ozogamicin for Older Patients With Relapsed or Refractory AML

Phase 1

Completed

Conditions: Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Pure Erythroid Leukemia (M6b)
Adult Acute Megakaryoblastic Leukemia (M7)

Interventions: Drug: vorinostat
Drug: gemtuzumab ozogamicin
Drug: azacitidine

First Posted Date: 2009-05-08

Last Posted Date: 2019-05-23

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 52

Registration Number: NCT00895934

Locations: 🇺🇸
Stanford University Hospitals and Clinics, Stanford, California, United States
🇺🇸
Fred Hutchinson Cancer Research Center, Seattle, Washington, United States
🇺🇸
University of Washington Medical Center, Seattle, Washington, United States

and more 1 locations

Phase 1-2 of Azacitidine + Lenalidomide for Previously Untreated Elderly Patients With Acute Myeloid Leukemia (AML)

Phase 1

Completed

Conditions: Acute Myeloid Leukemia (AML)
Adult Acute Myeloblastic Leukemia

Interventions: Drug: Lenalidomide
Drug: Azacitidine

First Posted Date: 2009-04-30

Last Posted Date: 2018-06-18

Lead Sponsor: Stanford University

Target Recruit Count: 45

Registration Number: NCT00890929

Locations: 🇺🇸
Stanford University School of Medicine, Stanford, California, United States

Controlled Study of Post-transplant Azacitidine for Prevention of Acute Myelogenous Leukemia and Myelodysplastic Syndrome Relapse (VZ-AML-PI-0129)

Phase 3

Completed

Conditions: Leukemia
AML
MDS

Interventions: Drug: Azacitidine

First Posted Date: 2009-04-23

Last Posted Date: 2020-01-14

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 187

Registration Number: NCT00887068

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

Azacitidine With Carboplatin and Paclitaxel for Newly Diagnosed Ovarian Cancer

Phase 1

Withdrawn

Conditions: Ovarian Cancer

Interventions: Drug: Azacitidine

First Posted Date: 2009-02-12

Last Posted Date: 2016-11-02

Lead Sponsor: Loyola University

Registration Number: NCT00842582

Locations: 🇺🇸
Central Dupage Hospital, Winfield, Illinois, United States
🇺🇸
Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center, Maywood, Illinois, United States

Azacitidine After Allo Blood And Marrow Transplantation (BMT) for Chronic Myelogenous Leukemia (CML)

Phase 2

Completed

Conditions: Stem Cell Transplantation
Leukemia

Interventions: Drug: Fludarabine
Drug: Busulfan
Drug: Thymoglobulin
Drug: Azacitidine
Procedure: Stem Cell Transplant

First Posted Date: 2008-12-22

Last Posted Date: 2021-02-11

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 24

Registration Number: NCT00813124

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

Safety & Pharmacokinetics Study Of Azacitidine (SC And Oral) In Subjects With MDS, CMML, AML, Lymphoma And Multiple Myeloma

Phase 1

Completed

Conditions: Leukemia, Myelomonocytic, Chronic
Myelodysplastic Syndromes
Lymphoma
Multiple Myeloma
Acute Myeloid Leukemia

Interventions: Drug: azacitidine

First Posted Date: 2008-09-29

Last Posted Date: 2019-11-08

Lead Sponsor: Celgene

Target Recruit Count: 31

Registration Number: NCT00761722

Locations: 🇺🇸
California Cancer Care Inc, Greenbrae, California, United States
🇺🇸
Main Cancer Centers of Florida, P.A., Ocoee, Florida, United States
🇺🇸
Indiana University School of Medicine, Indianapolis, Indiana, United States

and more 8 locations

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