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

Study of Vidaza (Azacitidine) Versus Support Treatment in Patients With Low Risk Myelodysplastic Syndrome (Low and Intermediate-1 IPSS) Without the 5q Deletion and Transfusion Dependent Anaemia

Phase 2

Completed

Conditions: Myelodysplastic Syndrome (MDS)

Interventions: Drug: Azacitidine

First Posted Date: 2011-04-19

Last Posted Date: 2016-01-26

Lead Sponsor: Asociación Andaluza de Hematología y Hemoterapia

Target Recruit Count: 40

Registration Number: NCT01338337

Locations: 🇪🇸
Hospital Carlos Haya, Malaga, Spain
🇪🇸
Hospital Universitario San Cecilio, Granada, Spain
🇪🇸
Hospital Costa del Sol, Marbella, Malaga, Spain

and more 6 locations

Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes

Phase 1

Withdrawn

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Ceplene®, IL-2, Azacitidine
Drug: Azacitidine

First Posted Date: 2011-03-29

Last Posted Date: 2014-03-20

Lead Sponsor: Groupe Francophone des Myelodysplasies

Registration Number: NCT01324960

Locations: 🇫🇷
CHU Cochin, Paris, Ile de France, France
🇫🇷
CHU Grenoble, Grenoble, France
🇫🇷
Hôpital Versailles, Le Chesnay, France

and more 25 locations

Intensified Azacitidine in High Risk Myelodysplastic Syndrome (MDS)

Phase 1

Completed

Conditions: Myelodysplastic Syndrome

Interventions: Drug: Azacitidine

First Posted Date: 2011-02-28

Last Posted Date: 2021-12-28

Lead Sponsor: Groupe Francophone des Myelodysplasies

Target Recruit Count: 27

Registration Number: NCT01305460

Locations: 🇫🇷
CHU d'Amiens, Amiens, France
🇫🇷
Centre henri Mondor, Creteil, France
🇫🇷
Centre Hospitalier de La Cote Basque, Bayonne, France

and more 18 locations

Elderly Patients With Acute Myeloid Leukemia (AML), Maintenance Phase After Complete Remission (CR)

Phase 2

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: azacitidine
Drug: Lenalidomide

First Posted Date: 2011-02-23

Last Posted Date: 2016-03-16

Lead Sponsor: French Innovative Leukemia Organisation

Target Recruit Count: 120

Registration Number: NCT01301820

Locations: 🇫🇷
Mathilde HUNAULT BERGER, Angers, France

Azacitidine in Treating Patients With Triple Negative Stage I-IV Invasive Breast Cancer That Can Be Removed By Surgery

Not Applicable

Withdrawn

Conditions: Recurrent Breast Cancer
Stage IIIC Breast Cancer
Stage IV Breast Cancer
Triple-negative Breast Cancer
Stage IB Breast Cancer
Stage II Breast Cancer
Stage IIIA Breast Cancer
Stage IIIB Breast Cancer
Stage IA Breast Cancer

Interventions: Drug: azacitidine
Other: laboratory biomarker analysis
Other: immunohistochemistry staining method
Genetic: polymerase chain reaction
Genetic: western blotting
Genetic: nucleic acid sequencing
Procedure: therapeutic conventional surgery

First Posted Date: 2011-02-09

Last Posted Date: 2014-02-06

Lead Sponsor: University of Southern California

Registration Number: NCT01292083

Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Phase 2

Completed

Conditions: Recurrent Lung Non-Small Cell Carcinoma
Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions: Drug: Azacitidine
Other: Diagnostic Laboratory Biomarker Analysis
Other: Pharmacological Study

First Posted Date: 2011-01-21

Last Posted Date: 2019-09-24

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 1

Registration Number: NCT01281124

Locations: 🇺🇸
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States

Azacitidine, Mitoxantrone Hydrochloride, and Etoposide in Treating Older Patients With Poor-Prognosis Acute Myeloid Leukemia

Phase 1

Terminated

Conditions: Adult Acute Eosinophilic Leukemia
Adult Acute Monoblastic Leukemia
Adult Acute Myeloid Leukemia in Remission
Adult Acute Myelomonocytic Leukemia
Adult Acute Basophilic Leukemia
Untreated Adult Acute Myeloid Leukemia
Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1
Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL

Interventions: Drug: Azacitidine
Drug: Etoposide
Other: Laboratory Biomarker Analysis
Drug: Mitoxantrone Hydrochloride

First Posted Date: 2010-12-15

Last Posted Date: 2015-08-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT01260714

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