Clinical trial NCT01378416: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Leukemia
Keywords: Acute myelogenous leukemia
myelodysplastic Syndrome
cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Average Total Body Clearance (Calculated From Rate and Concentration)
timeFrame: Day 1, Day 2, Day 3
measure: Cmax (Maximum Plasma Concentration)
timeFrame: Day 1, Day 2, Day 3
measure: Tmax (Time at Which Cmax First Observed)
timeFrame: Day 1, Day 2, Day 3
measure: AUC (0-∞) - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
timeFrame: Day 1, Day 2, day 3
Secondary outcomes:
measure: Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Eisai Medical Research (formerly MGI Pharma Inc.)
name: Gerard Kennealey, MD
role: STUDY_DIRECTOR
References: