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
- -
Vorinostat and Decitabine in Treating Patients With Relapsed, Refractory, or Poor-Prognosis Hematologic Cancer or Other Diseases
- Conditions
- Adult Acute Myeloid Leukemia With 11q23 (MLL) AbnormalitiesAdult Acute Myeloid Leukemia With Del(5q)Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)Chronic Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiablePhiladelphia Chromosome Negative Chronic Myelogenous LeukemiaPreviously Treated Myelodysplastic Syndromes
- Interventions
- First Posted Date
- 2006-07-27
- Last Posted Date
- 2013-01-07
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 50
- Registration Number
- NCT00357708
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
A Study of Low-Dose Decitabine in Relapsed or Refractory Acute Lymphocytic Leukemia (ALL)
- First Posted Date
- 2006-07-07
- Last Posted Date
- 2014-10-15
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 40
- Registration Number
- NCT00349596
- Locations
- 🇺🇸
University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Determination of Safe and Effective Dose of Romiplostim (AMG 531) in Subjects With Myelodysplastic Syndrome (MDS)Receiving Hypomethylating Agents
- Conditions
- MDSThrombocytopeniaMyelodysplastic Syndromes
- Interventions
- First Posted Date
- 2006-05-04
- Last Posted Date
- 2018-10-17
- Lead Sponsor
- Amgen
- Target Recruit Count
- 69
- Registration Number
- NCT00321711
Vorinostat and Decitabine in Treating Patients With Advanced Solid Tumors or Relapsed or Refractory Non-Hodgkin's Lymphoma, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, or Chronic Myelogenous Leukemia
- Conditions
- Nodal Marginal Zone B-cell LymphomaRecurrent Adult Diffuse Small Cleaved Cell LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaStage III Adult Immunoblastic Large Cell LymphomaStage III Grade 2 Follicular LymphomaAdult Acute Myeloid Leukemia With t(15;17)(q22;q12)Recurrent Adult Acute Myeloid LeukemiaRecurrent Adult Burkitt Lymphoma
- Interventions
- First Posted Date
- 2006-01-11
- Last Posted Date
- 2014-08-27
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 80
- Registration Number
- NCT00275080
- Locations
- 🇨🇦
Princess Margaret Hospital Phase 2 Consortium, Toronto, Ontario, Canada
🇨🇦Chedoke-McMaster Hospitals, Hamilton, Ontario, Canada
🇨🇦Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
A Study of Decitabine Given to Adults With Advanced-Stage Myelodysplastic Syndromes
- First Posted Date
- 2005-12-01
- Last Posted Date
- 2013-05-20
- Lead Sponsor
- Eisai Inc.
- Target Recruit Count
- 99
- Registration Number
- NCT00260065
Decitabine and FR901228 in Treating Patients With Relapsed or Refractory Leukemia, Myelodysplastic Syndromes, or Myeloproliferative Disorders
- Conditions
- Chronic Myeloproliferative DisordersLeukemiaMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative Neoplasms
- Interventions
- First Posted Date
- 2005-06-14
- Last Posted Date
- 2013-02-11
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 36
- Registration Number
- NCT00114257
- Locations
- 🇺🇸
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Low-Dose Decitabine in Myelodysplastic Syndrome Post Azacytidine Failure
- Conditions
- Myelodysplastic SyndromeChronic Myelomonocytic Leukemia
- Interventions
- First Posted Date
- 2005-06-08
- Last Posted Date
- 2012-08-07
- Lead Sponsor
- M.D. Anderson Cancer Center
- Target Recruit Count
- 16
- Registration Number
- NCT00113321
- Locations
- 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States
Decitabine With or Without Valproic Acid in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- Conditions
- Recurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Mantle Cell Lymphoma
- Interventions
- First Posted Date
- 2005-05-04
- Last Posted Date
- 2013-06-04
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 42
- Registration Number
- NCT00109824
- Locations
- 🇺🇸
Ohio State University Medical Center, Columbus, Ohio, United States
Decitabine in Treating Patients With Myelofibrosis
- Conditions
- Primary MyelofibrosisSecondary Myelofibrosis
- Interventions
- Drug: DecitabineOther: Laboratory Biomarker Analysis
- First Posted Date
- 2004-11-09
- Last Posted Date
- 2024-08-27
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 21
- Registration Number
- NCT00095784
- Locations
- 🇺🇸
University of Chicago Comprehensive Cancer Center, Chicago, Illinois, United States
🇺🇸University of Maryland/Greenebaum Cancer Center, Baltimore, Maryland, United States
🇺🇸Oncology Care Associates PLLC, Saint Joseph, Michigan, United States
Decitabine in Treating Patients With Melanoma or Other Advanced Cancer
- Conditions
- Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesPrecancerous ConditionUnspecified Adult Solid Tumor, Protocol Specific
- First Posted Date
- 2004-09-03
- Last Posted Date
- 2013-02-15
- Lead Sponsor
- California Cancer Consortium
- Registration Number
- NCT00002980
- Locations
- 🇺🇸
Beckman Research Institute, City of Hope, Duarte, California, United States
🇺🇸University of California Davis Cancer Center, Sacramento, California, United States
🇺🇸USC/Norris Comprehensive Cancer Center, Los Angeles, California, United States
Drug Development Updates
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