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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01201811
• Date of registration: 13/09/2010
• Prospective Registration: Yes
• Primary sponsor: Celgene
• Public title: Study of Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes (MDS)
• Scientific title: A Phase 4, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes.
• Date of first enrolment: October 1, 2010
• Target sample size: 44
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01201811
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Taiwan

Contacts

• Name: C L Beach, PharmD
• Affiliation: Celgene

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myelodysplastic Syndromes

Intervention(s)

Drug: Azacitidine

Primary Outcome(s)

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 [Time Frame: Response assessed at end of cycle 6; through week 24; End of study]

Percentage of Participants With a Hematologic Response Using International Working Group (IWG) Criteria for Myelodysplastic Syndrome (MDS) and Assessed by Investigator [Time Frame: Response assessed at end of cycle 6; through week 24; End of study]

Secondary Outcome(s)

Number of Platelet Transfusions by Cycle [Time Frame: Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.]

Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUCt) of Azacitidine [Time Frame: Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Number of Infections (Post-baseline Average) Requiring Intravenous Antibiotics, Anti-fungals, or Antivirals Per 28 Days [Time Frame: Up to week 24; The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.]

Number of Participants With Adverse Events (AE) [Time Frame: From the first dose of study drug through 28 days after completion of/discontinuation from the study (maximum time on study drug 244 days)]

Maximum Observed Plasma Concentration (Cmax) of Azacitidine [Time Frame: Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Terminal Phase of Half-life (T1/2) of Azacitidine [Time Frame: Timeframe: Day 7 pre-dose at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Apparent Total Plasma Clearance (CL/F) of Azacitidine [Time Frame: Timeframe: Days 5 and 6 at predose and Day 7 (pre-dose) at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Number of Red Blood Cell (RBC) Transfusions by Cycle [Time Frame: Up to week 24;The on-treatment period was considered the period from the date of the first dose to the last treatment study visit.]

Time to Maximum Plasma Concentration (Tmax) of Azacitidine [Time Frame: Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Apparent Volume of Distribution (Vd/F) of Azacitidine [Time Frame: Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC8) of Azacitidine [Time Frame: Timeframe: Day 7 pre-dose and at 0.25, 0.5, 1, 2, 3, 4, 6, 8 hours post-dose]

Secondary ID(s)

AZA-MDS-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/06/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01201811