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

Azacitidine and Interferon Alfa in Treating Patients With Metastatic Melanoma

Phase 1

Completed

Conditions: Melanoma (Skin)

First Posted Date: 2006-11-10

Last Posted Date: 2021-03-03

Lead Sponsor: University of California, San Diego

Target Recruit Count: 12

Registration Number: NCT00398450

Locations: 🇺🇸
Rebecca and John Moores UCSD Cancer Center, La Jolla, California, United States

Vorinostat and Azacitidine in Treating Patients With Myelodysplastic Syndromes or Acute Myeloid Leukemia

Phase 1

Active, not recruiting

Conditions: Acute Erythroid Leukemia
Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Refractory Anemia
Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndrome With Ring Sideroblasts
Acute Megakaryoblastic Leukemia
Myelodysplastic Syndrome With Excess Blasts

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

First Posted Date: 2006-10-26

Last Posted Date: 2024-08-02

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 135

Registration Number: NCT00392353

Locations: 🇺🇸
North Shore University Hospital, Manhasset, New York, United States
🇺🇸
University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸
Mount Sinai Hospital, New York, New York, United States

and more 4 locations

Maintenance Azacitidine in Elderly Patients With Acute Myeloid Leukemia (AML) in CR After Induction Chemotherapy

Phase 2

Completed

Conditions: Leukemia

Interventions: Drug: Azacitidine

First Posted Date: 2006-10-13

Last Posted Date: 2014-08-22

Lead Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Target Recruit Count: 24

Registration Number: NCT00387647

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, United States
🇺🇸
Duke University Medical Center, Durham, North Carolina, United States

A Phase II Study of Intravenous Azacitidine Alone in Patients With Myelodysplastic Syndromes

Phase 2

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Azacitidine

First Posted Date: 2006-10-06

Last Posted Date: 2016-12-12

Lead Sponsor: Washington University School of Medicine

Target Recruit Count: 25

Registration Number: NCT00384956

Locations: 🇺🇸
Washington University School of Medicine, St. Louis, Missouri, United States

Azacytidine With Valproic Acid Versus Ara-C in Acute Myeloid Leukemia (AML)/ Myelodysplastic Syndrome (MDS) Patients

Phase 2

Completed

Conditions: Acute Myelogenous Leukemia
Myelodysplastic Syndrome
Leukemia

Interventions: Drug: 5-Azacytidine
Drug: Ara-C
Drug: Valproic Acid (VPA)

First Posted Date: 2006-09-29

Last Posted Date: 2012-08-07

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 11

Registration Number: NCT00382590

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

Azacitidine in Treating Patients With Myelofibrosis

Phase 2

Terminated

Conditions: Chronic Myeloproliferative Disorders
Secondary Myelofibrosis

First Posted Date: 2006-09-28

Last Posted Date: 2011-04-21

Lead Sponsor: Mayo Clinic

Target Recruit Count: 10

Registration Number: NCT00381693

Locations: 🇺🇸
Mayo Clinic in Arizona, Scottsdale, Arizona, United States
🇺🇸
Mayo Clinic, Rochester, Minnesota, United States

Azacitidine and Erythropoietin Versus Azacitidine Alone for Patients With Low-Risk Myelodysplastic Syndromes

Phase 2

Terminated

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Azacitidine (Monotherapy)
Drug: Azacitidine
Drug: Erythropoietin

First Posted Date: 2006-09-25

Last Posted Date: 2018-02-14

Lead Sponsor: Larry Cripe, MD

Target Recruit Count: 15

Registration Number: NCT00379912

Locations: 🇺🇸
Center for Hematology-Oncology of S Michigan, Jackson, Michigan, United States
🇺🇸
Horizon Oncology Center, Lafayette, Indiana, United States
🇺🇸
Indiana University Cancer Center, Indianapolis, Indiana, United States

and more 6 locations

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

Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes

Phase 1

Completed

Conditions: Myelodysplastic Syndromes
Leukemia

Interventions: Drug: azacitidine
Drug: lenalidomide

First Posted Date: 2006-07-14

Last Posted Date: 2018-09-19

Lead Sponsor: Mikkael Sekeres MD

Target Recruit Count: 37

Registration Number: NCT00352001

Locations: 🇺🇸
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida, Tampa, Florida, United States
🇺🇸
University of California at Los Angeles, Los Angeles, California, United States
🇺🇸
Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

Azacitidine Maintenance Therapy After Allogeneic Bone Marrow Transplantation (Allo BMT)

Phase 1

Completed

Conditions: Myelodysplastic Syndrome
Leukemia

Interventions: Drug: Azacitidine

First Posted Date: 2006-07-11

Last Posted Date: 2012-07-30

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 90

Registration Number: NCT00350818

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

Drug Development Updates

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