CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 67 enrolled
Drug / intervention
decitabine +1 moredrug
Likely dose
decitabine 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00619099
NCT00619099Phase 2Completed
CompareCT.gov

Randomized Open-label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes

Eisai Inc.·interventional·Posted Feb 20, 2008·Updated Oct 24, 2013

In Brief

A Phase 2 clinical trial evaluating decitabine for Myelodysplastic Syndrome. Completed, enrolled 67 participants across 4 sites.

Detailed Summary

The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 18.4 years ago

Interventions

decitabinedrug

Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.

decitabinedrug

Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m\^2/day. One course will be considered 28 days.