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

• Status: Completed
• Trial end date: 2013-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Celgene; Celgene Corporation
• Treatments: Antimetabolites; Antimetabolites, Antineoplastic; Antineoplastic Agents; Azacitidine; Molecular Mechanisms of Pharmacological Action

Criteria

Inclusion Criteria:

• A diagnosis of RAEB or RAEB-T according to FAB classification for MDS and with an IPSS score of intermediate-2 or high risk or a diagnosis of myelodysplastic CMML per modified FAB criteria.

• Taiwanese males and females ≥ 18 years of age

• ECOG 0, 1, or 2;

• Adequate hepatic and renal organ function

Exclusion Criteria:

• Previous treatment with azacitidine or decitabine

• Malignant disease diagnosed within prior 12 months

• Uncorrected red cell folate deficiency or vitamin B12 deficiency

• Diagnosis of metastatic disease

• Malignant hepatic tumors

• Known or suspected hypersensitivity to azacitidine or mannitol

• Prior transplantation or cytotoxic therapy, including azacitidine and chemotherapy, administered to treat MDS

• Treatment with erythropoietin or myeloid growth factors during the 21 days prior to Day 1 of Cycle 1 or androgenic hormones during the 14 days prior to Day 1 of Cycle 1;

• Active HIV or viral hepatitis type B or C

• Treatment with other investigational drugs within the previous 30 days prior to Day 1 of Cycle 1, or ongoing adverse events from previous treatment with investigational drugs, regardless of the time period;

• Pregnant or lactating females