NCT00941109

Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

A Phase 1 Open-Label, Dose Escalation Study to Determine the Absolute Bioavailability of a Single Oral Dose Administration of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.

Detailed description

Cohorts are dosed sequentially, and escalation may stop before the 5th cohort is dosed. Each cycle will be approximately 4 weeks in length. Following Cycle 1, patients may receive an additional 4 follow-up cycles of decitabine. Cycles 2-5 will include a 20 mg/m\^2 1-hour IV infusion of decitabine on Days 1-5 for all cohorts.

Conditions

• Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	decitabine	Cohort 1: 30 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
DRUG	decitabine	Cohort 2: 60 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
DRUG	decitabine	Cohort 3: 120 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.
DRUG	decitabine	Cohort 4: 240 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-09-01
• Completion: 2012-09-01
• First posted: 2009-07-17
• Last updated: 2023-06-18

Locations

6 sites across 1 country: United States