Back to resultsPharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Decitabine (Dacogen)
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Acute myelogenous leukemia, myelodysplastic Syndrome, cancer
Eligibility Criteria
Inclusion Criteria:
Each patient had to meet the following criteria to be eligible for the study:
- 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.
- 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.
- Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- 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.
- 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).
- Must have had life expectancy of at least 12 weeks.
- Must have recovered from all toxic effects of all prior therapy before entry into this study.
Exclusion Criteria:
- Patients with MDS must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
- Must not have had acute promyelocytic leukemia (M3 classification).
- Must not have received immunosuppressive therapy for 30 days prior to study entry.
- Must not have had central nervous system (CNS) leukemia.
- 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Average Total Body Clearance (Calculated From Rate and Concentration)
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)
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)
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
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)
Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01378416
Brief Title
Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
January 2006 (Actual)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Acute myelogenous leukemia, myelodysplastic Syndrome, cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Decitabine (Dacogen)
Other Intervention Name(s)
Dacogen
Intervention Description
Intravenous injection; total dose-per-cycle was 135 mg/m^2 of decitabine.
Primary Outcome Measure Information:
Title
Average Total Body Clearance (Calculated From Rate and Concentration)
Description
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).
Time Frame
Day 1, Day 2, Day 3
Title
Cmax (Maximum Plasma Concentration)
Description
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).
Time Frame
Day 1, Day 2, Day 3
Title
Tmax (Time at Which Cmax First Observed)
Description
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).
Time Frame
Day 1, Day 2, Day 3
Title
AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
Description
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).
Time Frame
Day 1, Day 2, day 3
Secondary Outcome Measure Information:
Title
Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
Description
Summary of All Adverse Events (AEs) by Maximum Grade Occurring in >= 10% Patients
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Each patient had to meet the following criteria to be eligible for the study:
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.
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.
Must have had Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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.
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).
Must have had life expectancy of at least 12 weeks.
Must have recovered from all toxic effects of all prior therapy before entry into this study.
Exclusion Criteria:
Patients with MDS must not have been candidates for high-dose chemotherapy, bone marrow or stem cell transplant.
Must not have had acute promyelocytic leukemia (M3 classification).
Must not have received immunosuppressive therapy for 30 days prior to study entry.
Must not have had central nervous system (CNS) leukemia.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gerard Kennealey, MD
Organizational Affiliation
Eisai Medical Research (formerly MGI Pharma Inc.)
Official's Role
Study Director
Facility Information:
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Trial of Decitabine (Dacogen) Administered as a 3-hour Infusion to Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
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