Phase 4
Completed N=44
Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
Source: ClinicalTrials.gov NCT01201811 ↗Enrolled (actual)
44
Serious AEs
63.6%
Results posted
Jun 2014
Primary outcomePrimary: Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator — 0; 63.6; 0.0; 0.0 percentage of participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator |
0; 63.6; 0.0; 0.0; 63.6; 2.3 | — |
| PRIMARY Percentage of Participants Showing Hematologic Improvement Using International Working Group (IWG Criteria for Hematologic Improvement Cheson 2000) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Sponsor |
50.0; 31.8; 9.1; 37.8; 0; 7.1 | — |
| SECONDARY Number of Red Blood Cell (RBC) Transfusions by Cycle |
1.3; 2.4; 1.0; 2.5; 2.3; 2.2 | — |
| SECONDARY Number of Platelet Transfusions by Cycle |
0.9; 2.7; 1.8; 2.6; 2.3; 3.0 | — |
| SECONDARY Number of Infections (Post-baseline Average) Requiring Intravenous Antibiotics, Anti-fungals, or Antivirals Per 28 Days |
0.1; 0.5; 0.4; 0.5; 0.4; 0.4 | — |
| SECONDARY Number of Participants With Adverse Events (AE) |
44; 37; 34; 22; 28; 24 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Azacitidine |
859.1 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine |
852.8 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Azacitidine |
972.3 | — |
| SECONDARY Time to Maximum Plasma Concentration (Tmax) of Azacitidine |
0.29 | — |
| SECONDARY Terminal Phase of Half-life (T1/2) of Azacitidine |
1.0 | — |
| SECONDARY Apparent Total Plasma Clearance (CL/F) of Azacitidine |
149.6 | — |
| SECONDARY Apparent Volume of Distribution (Vd/F) of Azacitidine |
205.3 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01201811). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.