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

NCT ID: NCT01378416

Last Updated: 2011-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-04-30
• Study Completion Date: 2007-06-30

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).

Conditions

Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Decitabine (Dacogen)

Intervention Type: DRUG

Intravenous injection; total dose-per-cycle was 135 mg/m\^2 of decitabine.

Interventions

Decitabine (Dacogen)

Intravenous injection; total dose-per-cycle was 135 mg/m\^2 of decitabine.

Intervention Type: DRUG

Other Intervention Names

Dacogen

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Eisai Medical Research Inc.

Principal Investigators

Gerard Kennealey, MD

Role: STUDY_DIRECTOR

Eisai Medical Research (formerly MGI Pharma Inc.)

Locations

Washington University School of Medicine

St Louis, Missouri, United States

Countries

United States

Other Identifiers

DACO-018

Identifier Type: -

Identifier Source: org_study_id