Decitabine

Generic Name
Decitabine
Brand Names
Dacogen, Inqovi 5 Tablet Pack
Drug Type
Small Molecule
Chemical Formula
C8H12N4O4
CAS Number
2353-33-5
Unique Ingredient Identifier
776B62CQ27
Background

Myelodysplastic syndromes (MDS) are a heterogeneous group of hematopoietic neoplasms with variable underlying etiology and presentation, including neutropenia and thrombocytopenia. Further mutations leading to increased proliferation of cancerous cells can eventually lead to secondary acute myeloid leukemia, which has a poor prognosis. Among treatment options, nucleoside analogues such as decitabine and azacitidine integrate into cellular DNA and inhibit the action of DNA methyltransferases, leading to global hypomethylation and related downstream therapeutic benefits.

Decitabine was developed by MGI Pharma/SuperGen Inc. and was approved by the FDA for the treatment of MDS on February 5, 2006. It was first marketed under the name Dacogen®. It is also available as an oral combination product together with the cytidine deaminase inhibitor cedazuridine.

Indication

Decitabine is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia), as well as for MDS scored as belonging to the intermediate-1, intermediate-2, or high-risk group in the International Prognostic Scoring System.

Associated Conditions
Chronic Myelomonocytic Leukemia, Myelodysplastic Syndrome
Associated Therapies
-

Decitabine and Talazoparib in Untreated AML and R/R AML

Phase 1
Completed
Conditions
Interventions
First Posted Date
2016-08-25
Last Posted Date
2023-03-29
Lead Sponsor
University of Maryland, Baltimore
Target Recruit Count
25
Registration Number
NCT02878785
Locations
🇺🇸

University of Maryland Greenebaum Comprehensive Cancer Center, Baltimore, Maryland, United States

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies

First Posted Date
2016-07-27
Last Posted Date
2019-01-07
Lead Sponsor
Yogen Saunthararajah
Target Recruit Count
7
Registration Number
NCT02846935
Locations
🇺🇸

Cleveland Clinic Taussig Cancer Center, Case Comprehensive Cancer Center, Cleveland, Ohio, United States

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer

First Posted Date
2016-07-27
Last Posted Date
2019-01-09
Lead Sponsor
Yogen Saunthararajah
Target Recruit Count
13
Registration Number
NCT02847000
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

Vadastuximab Talirine (SGN-CD33A; 33A) Combined With Azacitidine or Decitabine in Older Patients With Newly Diagnosed Acute Myeloid Leukemia

First Posted Date
2016-05-30
Last Posted Date
2018-12-12
Lead Sponsor
Seagen Inc.
Target Recruit Count
240
Registration Number
NCT02785900
Locations
🇺🇸

University of Kansas Cancer Center, Westwood, Kansas, United States

🇺🇸

LSU Health Sciences Center / Feist Weiller Cancer Center, Shreveport, Louisiana, United States

🇺🇸

Rush University Medical Center, Chicago, Illinois, United States

and more 125 locations

A Clinical Trial Evaluating the Efficacy of Ultra Low Dose of Decitabine in Myelodysplastic Syndromes (MDS)

Not Applicable
Conditions
Interventions
First Posted Date
2016-05-20
Last Posted Date
2017-11-08
Lead Sponsor
The First Affiliated Hospital with Nanjing Medical University
Target Recruit Count
80
Registration Number
NCT02779569
Locations
🇨🇳

No.303 Hospital of Chinese People's Liberation Army, Nanning, Guangxi, China

🇨🇳

Shengjing Hospital of China Medical Univercity, Shenyang, Liaoning, China

🇨🇳

Jiangsu Province Hospital, Nanjing, Jiangsu, China

and more 3 locations

G-CSF+Decitabine+BUCY vs BUCY Conditioning Regimen for RAEB-1, REAB-2 and AML Secondary to MDS Undergoing Allo-HSCT

First Posted Date
2016-04-20
Last Posted Date
2022-02-14
Lead Sponsor
Nanfang Hospital, Southern Medical University
Target Recruit Count
202
Registration Number
NCT02744742
Locations
🇨🇳

Department of Hematology,Nanfang Hospital, Southern Medical University, Guangzhou, Guangdong, China

Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

First Posted Date
2016-03-03
Last Posted Date
2016-03-07
Lead Sponsor
Ulsan University Hospital
Target Recruit Count
136
Registration Number
NCT02698124
Locations
🇰🇷

Ulsan University Hospital, Ulsan, Korea, Republic of

Decitabine Combined With Gemcitabine in First-line Treatment of AdvancedPancreatic Cancer

Not Applicable
Conditions
Interventions
First Posted Date
2016-02-18
Last Posted Date
2016-02-18
Lead Sponsor
The First Hospital of Jilin University
Target Recruit Count
20
Registration Number
NCT02685228
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