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

NCT00941109 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2023-06-18

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Eisai US Medical Services · Eisai Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-09-30
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00941109 on ClinicalTrials.gov