NEWS HIGHLIGHTS
Published Studies Related to Vidaza (Azacitidine Subcutaneous)
Hematologic response to three alternative dosing schedules of azacitidine in patients with myelodysplastic syndromes. [2009.04.10]
PURPOSE: Azacitidine (AZA) is effective treatment for myelodysplastic syndromes (MDS) at a dosing schedule of 75 mg/m(2)/d subcutaneously for 7 days every 4 weeks. The initial phase of this ongoing multicenter, community-based, open-label study evaluated three alternative AZA dosing schedules without weekend dosing... CONCLUSION: All three alternative dosing regimens produced HI, RBC transfusion independence, and safety responses consistent with the currently approved AZA regimen. These results support AZA benefits in transfusion-dependent lower-risk MDS patients.
A limited number of 5-azacitidine cycles can be effective treatment in MDS. [2009.03]
Hypomethylating agents, such as 5-azacitidine (5-AZA) and 5-aza-2'-deoxycytidine (decitabine), have recently been approved for the treatment of myelodysplastic syndromes (MDS). Several randomized trials have shown favorable results concerning response rate, survival, transformation to acute leukemia, and quality of life...
Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study. [2009.03]
BACKGROUND: Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens... INTERPRETATION: Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care.
A limited number of 5-azacitidine cycles can be effective treatment in MDS. [2008.08.12]
Hypomethylating agents, such as 5-azacitidine (5-AZA) and 5-aza-2'-deoxycytidine (decitabine), have recently been approved for the treatment of myelodysplastic syndromes (MDS). Several randomized trials have shown favorable results concerning response rate, survival, transformation to acute leukemia, and quality of life...
Approval summary: azacitidine for treatment of myelodysplastic syndrome subtypes. [2005.05.15]
CONCLUSIONS: On May 19, 2004 the U.S. Food and Drug Administration approved azacitidine as injectable suspension for treatment of patients with the following myelodysplastic syndrome subtypes: refractory anemia or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia. Full prescribing information is available at http://www.fda.gov/cder/foi/label/2004/050794lbl.pdf. Azacitidine is the first agent approved for treatment of myelodysplastic syndrome.
Clinical Trials Related to Vidaza (Azacitidine Subcutaneous)
Azacitidine and Cisplatin for Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck [Terminated]
To evaluate the safety and toxicity of azacitidine (5-azacitidine, Vidaza®) and cisplatin
combination in patients with squamous cell carcinoma of head and neck (SCCHN).
Ph II Study of Azacitidine in Myelofibrosis [Active, not recruiting]
The goal of this clinical research study is to learn if azacitidine can help to control MF.
The safety of azacitidine in patients with MF will also be studied.
Optional Procedures: You will be asked to have additional blood samples and bone marrow
samples collected. These samples will be used to evaluate important characteristics of MF
before and during the therapy with azacitidine.
Vidaza to Restore Hormone Thx Prostate [Active, not recruiting]
The purpose of this research study is to find out what effects (good and bad) Vidaza has on
patients with prostate cancer. This investigational drug is not approved by the Food and
Drug Administration (FDA) for the treatment of prostate cancer; however, it is approved in
myelodysplastic syndrome - a bone marrow disease. The pharmaceutical company involved in
this study, Pharmion Corporation, is the manufacturer of Vidaza.
Ph I Study of PXD101 and 5-Aza in Advanced Hematologic Malignancies [Recruiting]
The purpose of this study is to find the highest safe dose of PXD101 in combination with 5-Aza that can be given without serious side effects in patients with advanced blood cancers (such as ALL, AML, CML, and MDS).
In addition, it will look at the safety and side effects (both good and bad) that PXD101 has on cancer when given in combination with 5-Aza.
MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia [Active, not recruiting]
RATIONALE: MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed
for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to
stop the growth of cancer cells, either by killing the cells or by stopping them from
dividing. Giving MS-275 together with azacitidine may kill more cancer cells.
PURPOSE: This phase I trial is studying the side effects and best dose of MS-275 when given
together with azacitidine in treating patients with myelodysplastic syndromes, chronic
myelomonocytic leukemia, or acute myeloid leukemia.
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