CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 39 enrolled
Drug / intervention
JNJ-30979754 15 mg/m2 +1 moredrug
Likely dose
JNJ-30979754 15 mg/m2from 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/NCT00796003
NCT00796003Phase 1Completed
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A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome

Janssen Pharmaceutical K.K.·interventional·Posted Nov 24, 2008·Updated Dec 9, 2013

In Brief

A Phase 1 clinical trial evaluating JNJ-30979754 15 mg/m2 and JNJ-30979754 20 mg/m2 for Myelodysplastic Syndrome. Completed, enrolled 39 participants across 7 sites.

Detailed Summary

The purpose of this study is to to determine the recommended dose level of JNJ-30979754 (decitabine) as well as to assess the safety and effectiveness in patients with Myelodysplastic Syndrome (MDS).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndrome
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 24, 2008
Enrollment StartJul 1, 2008
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 17.6 years ago

Interventions

JNJ-30979754 15 mg/m2drug

JNJ-30979754 (decitabine) 15 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1.

JNJ-30979754 20 mg/m2drug

Phase I: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1. Phase II: JNJ-30979754 (decitabine) 20 mg/m2 will be administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles until the decitabine was expected to be effective in participants.