A Clinical Pharmacology and Exploratory Study of Decitabine Injection in Myelodysplastic Syndrome.
The objectives of this study are: Phase 1 part: To assess the safety and the recommended dose of decitabine, Phase 2 part: To assess the efficacy and safety of the recommended dose of decitabine confirmed in the phase I part.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I/II Clinical Study of JNJ-30979754 (Decitabine) in Patients With Myelodysplastic Syndrome|
- To assess the safety and recommended dose in phase 1 part. To assess the efficacy by remission rate (complete remission + partial remission) in phase 2 part.
- Time to remission, duration of remission, time to progression to Acute Myeloid Leukemia (AML) or death, therapeutic response (complete remission + partial remission + hematologic improvement), transfusion frequency, cytogenetic response
|Study Start Date:||July 2008|
|Study Completion Date:||October 2010|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
This is a phase 1/2, open-label (both physician and patient know the name and dosage of drug), multi-center trial in Myelodysplastic Syndrome (MDS). The purpose of this study is to assess the safety and efficacy of decitabine as well as to determine the recommended dose in patients with MDS. This trial consists of two parts, phase 1 part and phase 2 part.
Phase 1 part: The objectives of phase 1 part are to assess the safety of decitabine and to determine the recommended dose for MDS. The dosage is 15mg/m2/day or 20mg/m2/day by 1-hour IV infusion for 5 consecutive days. Primary measures of this phase 1 part include adverse events. In patients enrolled in the phase I part, pharmacokinetics and pharmacodynamics of decitabine will also be analyzed.
Phase 2 part: The objectives of phase 2 part are to assess the efficacy and safety of decitabine. The initial dose (dose level 1) is set at 15 mg/m2/day. When the dose of 20 mg/m2/day (dose level 2) is confirmed to be well tolerated in the phase 1 part, patients will be added to the dose level 2 group until a total number of 26 patients to evaluate the efficacy and safety of decitabine in the phase 2 part. The primary efficacy endpoint is remission rate (complete remission + partial remission) at the end of study. One hour intravenous infusion (using an infusion pump) for 5 consecutive days
|Nagoya N/A, Japan|
|Study Director:||Janssen Pharmaceutical K.K. Clinical Trial||Janssen Pharmaceutical K.K.|