Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

NCT00941109 | Completed Phase 1

• 1 other identifier: E7373-A001-101
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this study is to determine how the body absorbs decitabine when taken orally in patients with Myelodysplastic Syndrome (MDS). Safety will also be assessed for this oral dose.

Conditions

Myelodysplastic Syndrome

Keywords

MDS

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetic (PK) endpoints will be decitabine PK parameters: Tmax, Cmax, AUC0-inf, t1/2 and F.

  Cycle 1 on Days 1 and 2 from predose up to 6 hours after administration.

Secondary Outcomes (1)

• Safety evaluations will include assessments of adverse events (AEs), medical history, physical examinations, vital signs measurements, use of concomitant medications, and laboratory assessments at baseline and throughout the study period.

  Up to 30 days after the last dose of decitabine

Study Arms (4)

1

EXPERIMENTAL

Drug: decitabine

2

EXPERIMENTAL

Drug: decitabine

3

EXPERIMENTAL

Drug: decitabine

4

EXPERIMENTAL

Drug: decitabine

Interventions

decitabine DRUG

Cohort 1: 30 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

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:

• Histologically confirmed de novo or secondary MDS.
• Age greater than or equal to 18 years.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• Adequate renal and hepatic function (creatinine less than or equal to 2.0 mg/dL, total bilirubin less than 2.0 mg/dL, aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] less than 3 times the upper limit of normal).
• Life expectancy of at least 6 weeks.
• If currently receiving 5 day decitabine regimen, patient must be scheduled to receive one more cycle of 5 day decitabine.
• Recovered from all toxic effects of all prior therapy before entry into this study.
• Women of childbearing potential and all men must agree to practice a medically approved form of contraception (one of the following must be used: condoms \[male or female\] with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, intrauterine device, hormonal contraception, abstinence) during the course of the study and up to 2 months following the last dose of decitabine.

You may not qualify if:

• Candidates for up front high dose induction chemotherapy. MDS patients who are scheduled to receive decitabine prior to a bone marrow transplant or stem cell transplant are allowed.
• History of treatment failure with decitabine.
• Received any experimental agent within the preceding 30 days prior to screening.
• Uncontrolled cardiac or pulmonary disease.
• History of intestinal surgery, pancreatic surgery, or gastric surgery.
• Any clinically relevant disease, disorder (including psychiatric disorders), or condition, in the opinion of the Investigator, which may interfere with the objectives of the study, especially with the gastrointestinal (GI) absorption of the study drug, and/or with the safety of the subject in the study.
• Current active colitis of any etiology (Clostridium difficile colitis, ulcerative colitis, Crohn's disease, etc.) or a recent (less than 2 weeks) episode of colitis.
• Pregnant or lactating. Female patients of childbearing potential must have had a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to dosing.
• Known positive serology for human immunodeficiency virus (HIV).
• Active viral, fungal, or bacterial infection. No patient may enter the study unless infections have been fully treated.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (6)

Unknown Facility

Scottsdale, Arizona, United States

Location

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Rochester, Minnesota, United States

Location

Unknown Facility

The Bronx, New York, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic 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

Study Officials

• Eisai US Medical Services

  Eisai Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2009
• First Posted: July 17, 2009
• Study Start: December 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: June 18, 2023

Record last verified: 2016-04

Locations

US (6)