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 in Treating Patients With Chronic Myelomonocytic Leukemia

Phase 2

Completed

Conditions: Leukemia

First Posted Date: 2010-11-05

Last Posted Date: 2013-08-26

Lead Sponsor: University of Leeds

Target Recruit Count: 30

Registration Number: NCT01235117

Locations: 🇬🇧
Leeds Cancer Centre at St. James's University Hospital, Leeds, England, United Kingdom
🇬🇧
Beatson West of Scotland Cancer Centre, Glasgow, Scotland, United Kingdom

Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery

Phase 2

Terminated

Conditions: Stage IB Non-Small Cell Lung Carcinoma
Stage IA Non-Small Cell Lung Carcinoma

Interventions: Drug: Azacitidine
Drug: Entinostat
Other: Laboratory Biomarker Analysis

First Posted Date: 2010-09-23

Last Posted Date: 2019-02-05

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 13

Registration Number: NCT01207726

Locations: 🇺🇸
Anne Arundel Medical Center, Annapolis, Maryland, United States
🇺🇸
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
🇺🇸
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States

and more 6 locations

PKC412 and 5-Azacytidine

Phase 1

Completed

Conditions: Leukemia

Interventions: Drug: 5-azacytidine
Drug: PKC412

First Posted Date: 2010-09-16

Last Posted Date: 2018-10-16

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 54

Registration Number: NCT01202877

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

Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)

Phase 4

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Azacitidine

First Posted Date: 2010-09-15

Last Posted Date: 2019-12-05

Lead Sponsor: Celgene

Target Recruit Count: 44

Registration Number: NCT01201811

Locations: 🇨🇳
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung City, Taiwan
🇨🇳
National Cheng Kung University Hospital, Tainan, Taiwan
🇨🇳
Changhua Christian Hospital, Changhua, Taiwan

and more 8 locations

Study of Grifola Frondosa (Maitake), Azacitidine, and Lenalidomide

Phase 1

Terminated

Conditions: Advanced Cancers

Interventions: Drug: Azacitidine
Drug: Lenalidomide
Drug: Grifola Frondosa

First Posted Date: 2010-09-13

Last Posted Date: 2013-08-02

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 1

Registration Number: NCT01200004

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

Azacitidine and CAPOX in Metastatic Colorectal Cancer

Phase 1

Completed

Conditions: Colorectal Cancer

Interventions: Drug: Azacitidine
Drug: Oxaliplatin
Drug: Capecitabine
Drug: Azacitidine MTD

First Posted Date: 2010-09-02

Last Posted Date: 2020-04-15

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 26

Registration Number: NCT01193517

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

An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)

Phase 3

Completed

Conditions: Myelodysplastic Syndromes

Interventions: Drug: Azacitidine

First Posted Date: 2010-08-23

Last Posted Date: 2019-11-14

Lead Sponsor: Celgene

Target Recruit Count: 40

Registration Number: NCT01186939

Trial Evaluating Induction Therapy With Idarubicin and Etoposide Plus Sequential or Concurrent Azacitidine and Maintenance Therapy With Azacitidine

Phase 2

Completed

Conditions: Acute Myeloid Leukemia (AML)

Interventions: Drug: Cytarabine
Drug: Idarubicin
Drug: Etoposide
Drug: Lenograstim
Drug: Azacitidine

First Posted Date: 2010-08-12

Last Posted Date: 2020-12-31

Lead Sponsor: University of Ulm

Target Recruit Count: 277

Registration Number: NCT01180322

Locations: 🇦🇹
Universitätsklinikum Innsbruck, Innsbruck, Austria
🇩🇪
Universitätsklinikum Schleswig-Holstein, Kiel, Germany
🇦🇹
Krankenhaus der Barmherzigen Schwestern, Linz, Austria

and more 40 locations

Busulfan, Fludarabine Phosphate, and Anti-Thymocyte Globulin Followed By Donor Stem Cell Transplant and Azacitidine in Treating Patients With High-Risk Myelodysplastic Syndrome and Older Patients With Acute Myeloid Leukemia

Phase 2

Completed

Conditions: Adult Acute Monoblastic Leukemia
Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11
Myelodysplastic Syndrome
Recurrent Adult Acute Myeloid Leukemia
Adult Acute Megakaryoblastic Leukemia
Adult Acute Monocytic Leukemia
Adult Acute Myeloid Leukemia With Maturation
Adult Acute Myeloid Leukemia With t(9;11)(p21.3;q23.3); MLLT3-MLL
Secondary Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia With Minimal Differentiation

Interventions: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation
Biological: Anti-Thymocyte Globulin
Drug: Azacitidine
Drug: Busulfan
Drug: Fludarabine Phosphate
Other: Laboratory Biomarker Analysis
Drug: Methotrexate
Other: Pharmacological Study
Drug: Tacrolimus

First Posted Date: 2010-07-23

Last Posted Date: 2022-08-04

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 68

Registration Number: NCT01168219

Locations: 🇺🇸
Northwell Health NCORP, Lake Success, New York, United States
🇺🇸
University of Iowa/Holden Comprehensive Cancer Center, Iowa City, Iowa, United States
🇺🇸
Mount Sinai Hospital, New York, New York, United States

and more 14 locations

Low-Dose Azacitidine, Lenalidomide, and Low-Dose Dexamethasone in Relapsed or Refractory Multiple Myeloma

Phase 1

Completed

Conditions: Refractory Multiple Myeloma

Interventions: Drug: azacitidine
Drug: lenalidomide
Drug: dexamethasone
Other: DNA methylation analysis
Other: gene expression analysis
Other: bone marrow aspiration
Other: immunohistochemistry staining method
Other: reverse transcriptase-polymerase chain reaction
Other: flow cytometry

First Posted Date: 2010-07-02

Last Posted Date: 2020-11-16

Lead Sponsor: Case Comprehensive Cancer Center

Target Recruit Count: 45

Registration Number: NCT01155583

Locations: 🇺🇸
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
🇺🇸
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

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