MedTrace Logo

An Expanded Access Program for Decitabine in Patients With Myelodysplastic Syndrome (MDS)

NCT01026376 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2013-04-18

No results posted yet for this study

Summary

The purpose of this study is to provide Decitabine to patients with Myelodysplastic syndrome (MDS) of all FAB (French-American-British) subtypes and Intermediate-1, Intermediate-2, and High-Risk International Prognostic Scoring System groups, including both previously treated and untreated patients.

Conditions

Interventions

DRUG

decitabine

Cycles of 15mg/m2 infusion during 3h, 3 times a day, per 3 days

DRUG

decitabine

Cycles of 20mg/m2 infusion during 1h, once a day, per 5 days

Sponsors & Collaborators

  • Janssen Korea, Ltd., Korea

    collaborator INDUSTRY

  • Janssen-Cilag Farmaceutica Ltda.

    lead INDUSTRY

Principal Investigators

  • Janssen-Cilag Farmaceutica Ltda. Clinical Trial · Janssen-Cilag Farmaceutica Ltda.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Brazil
  • Hong Kong
  • Thailand

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 NCT01026376 on ClinicalTrials.gov