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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01378416
First Posted: June 22, 2011
Last Update Posted: July 12, 2011
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.
Information provided by:
Eisai Inc.
  Purpose
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).

Condition Intervention Phase
Leukemia Drug: Decitabine (Dacogen) Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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


Enrollment: 16
Study Start Date: April 2005
Study Completion Date: June 2007
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Decitabine (Dacogen)
Intravenous injection; total dose-per-cycle was 135 mg/m^2 of decitabine.
Other Name: Dacogen

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01378416


Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Gerard Kennealey, MD Eisai Medical Research (formerly MGI Pharma Inc.)
  More Information

Responsible Party: Gerard Kennealey, MD, Eisai Medical Research Inc.
ClinicalTrials.gov Identifier: NCT01378416     History of Changes
Other Study ID Numbers: DACO-018
First Submitted: September 30, 2008
First Posted: June 22, 2011
Results First Submitted: September 30, 2008
Results First Posted: June 22, 2011
Last Update Posted: July 12, 2011
Last Verified: July 2011

Keywords provided by Eisai Inc.:
Acute myelogenous leukemia
myelodysplastic Syndrome
cancer

Additional relevant MeSH terms:
Leukemia
Myelodysplastic Syndromes
Preleukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Decitabine
Azacitidine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors