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

NCT01378416 | Completed Phase 1 Results

• 1 other identifier: DACO-018
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

Acute myelogenous leukemia; myelodysplastic Syndrome; cancer

Outcome Measures

Primary Outcomes (4)

• 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).

  Day 1, Day 2, 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).

  Day 1, Day 2, 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).

  Day 1, Day 2, 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).

  Day 1, Day 2, day 3

Secondary Outcomes (1)

• Safety: The Most Frequently Reported Adverse Events (Regardless of Causality)

  6 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Decitabine (Dacogen)

Interventions

Decitabine (Dacogen) DRUG

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

Also known as: Dacogen

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Neoplasms

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Myeloid; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Results Point of Contact

• Title: Yufang Lu, MD PhD
• Organization: Eisai Inc.

1-888-422-4743

Study Officials

• Gerard Kennealey, MD

  Eisai Medical Research (formerly MGI Pharma Inc.)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 30, 2008
• First Posted: June 22, 2011
• Study Start: April 1, 2005
• Primary Completion: January 1, 2006
• Study Completion: June 1, 2007
• Last Updated: July 12, 2011
• Results First Posted: June 22, 2011

Record last verified: 2011-07

Locations

US (1)