NCT01571648

A Phase 1 Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Patients With Myelodysplastic Syndromes

A Phase 1, Multicenter, Open-label Study to Evaluate the Pharmacokinetics and Tolerability of Oral Azacitidine in Japanese Subjects With Myelodysplastic Syndromes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the tolerability of oral azacitidine in the treatment of patients with Myelodysplastic Syndromes (MDS).

Conditions

• Myelodysplastic Syndromes

Interventions

Type	Name	Description
DRUG	Oral azacitidine	Patients will receive 300 mg dose of oral azacitidine administered once daily for the first 21 days of each 28-day treatment cycle.

Timeline

• Start date: 2012-04-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2012-04-05
• Last updated: 2019-11-12

Locations

5 sites across 1 country: Japan