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Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01378416
Recruitment Status : Completed
First Posted : June 22, 2011
Results First Posted : June 22, 2011
Last Update Posted : July 12, 2011
Sponsor:
Information provided by:
Eisai Inc.

Tracking Information
First Submitted Date  ICMJE September 30, 2008
First Posted Date  ICMJE June 22, 2011
Results First Submitted Date  ICMJE September 30, 2008
Results First Posted Date  ICMJE June 22, 2011
Last Update Posted Date July 12, 2011
Study Start Date  ICMJE April 2005
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
  • Average Total Body Clearance (Calculated From Rate and Concentration) [ Time Frame: Day 1, Day 2, Day 3 ]
    3-hour IV infusion, every 8 hours for three consecutive days. Average Total Body Clearance was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
  • Cmax (Maximum Plasma Concentration) [ Time Frame: Day 1, Day 2, Day 3 ]
    3-hour IV infusion, every 8 hours for three consecutive days. Cmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
  • Tmax (Time at Which Cmax First Observed) [ Time Frame: Day 1, Day 2, Day 3 ]
    3-hour IV infusion, every 8 hours for three consecutive days. Tmax was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
  • AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity [ Time Frame: Day 1, Day 2, day 3 ]
    3-hour IV infusion, every 8 hours for three consecutive days. AUC (0-∞) was measured post first dose (Day 1), fourth dose (Day 2), and seventh dose (Day 3).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 25, 2011)
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality) [ Time Frame: 6 weeks ]
Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Official Title  ICMJE A Phase I Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Brief Summary The purpose of this study is to determine the pharmacokinetics (PK) of decitabine administered to patients with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Leukemia
Intervention  ICMJE Drug: Decitabine (Dacogen)
Intravenous injection; total dose-per-cycle was 135 mg/m^2 of decitabine.
Other Name: Dacogen
Study Arms  ICMJE Experimental: 1
Intervention: Drug: Decitabine (Dacogen)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2011)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date January 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Each patient had to meet the following criteria to be eligible for the study:

  1. Patients with MDS (de novo or secondary) must have been 60 years or older and have had disease fitting any of the recognized French-American-British classifications OR chronic myelomonocytic leukemia (with white blood cell [WBC] <12,000/μL) AND have had an International Prognostic Scoring System score of ≥1.5 as determined by complete blood count, bone marrow assessment and bone marrow cytogenetics within 30 days of study entry.
  2. Patients with AML (≥30% bone marrow blasts) must have been age 18 years or older and had previously received standard induction chemotherapy and/or had failed approved therapies.
  3. Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
  4. Must have signed an Institutional Review Board (IRB)-approved informed consent form, indicating his/her awareness of the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
  5. Must have had adequate renal and hepatic function (creatinine ≤2.0 mg/dL, total bilirubin <2.0 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <3.0 X institutional upper limit of normal).
  6. Must have had life expectancy of at least 12 weeks.
  7. Must have recovered from all toxic effects of all prior therapy before entry into this study.

Exclusion Criteria:

  1. Patients with MDS must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
  2. Must not have had acute promyelocytic leukemia (M3 classification).
  3. Must not have received immunosuppressive therapy for 30 days prior to study entry.
  4. Must not have had central nervous system (CNS) leukemia.
  5. Must not have received systemic corticosteroids, interferon, interleukins or other hormonal therapy within 30 days prior to study entry. Use of corticosteroids (topical and inhaled corticosteroids) was permitted and prophylactic steroids may have been used to treat or prevent transfusion reactions.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01378416
Other Study ID Numbers  ICMJE DACO-018
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gerard Kennealey, MD, Eisai Medical Research Inc.
Study Sponsor  ICMJE Eisai Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gerard Kennealey, MD Eisai Medical Research (formerly MGI Pharma Inc.)
PRS Account Eisai Inc.
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP