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

NCT ID: NCT00941109

Last Updated: 2023-06-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-09-30

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.

Detailed Description

Cohorts are dosed sequentially, and escalation may stop before the 5th cohort is dosed. Each cycle will be approximately 4 weeks in length. Following Cycle 1, patients may receive an additional 4 follow-up cycles of decitabine. Cycles 2-5 will include a 20 mg/m^2 1-hour IV infusion of decitabine on Days 1-5 for all cohorts.

Conditions

Myelodysplastic Syndrome

Study Design

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

Study Groups

1

Group Type: EXPERIMENTAL

decitabine

Intervention Type: 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.

2

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Cohort 2: 60 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

3

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Cohort 3: 120 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

4

Group Type: EXPERIMENTAL

decitabine

Intervention Type: DRUG

Cohort 4: 240 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

Interventions

decitabine

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

Intervention Type: DRUG

decitabine

Cohort 2: 60 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

Intervention Type: DRUG

decitabine

Cohort 3: 120 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

Intervention Type: DRUG

decitabine

Cohort 4: 240 mg oral on Day 1 and 20 mg/m\^2 1-hour IV infusion on Days 2-5 of Cycle 1.

Intervention Type: DRUG

Other Intervention Names

Dacogen; Dacogen; Dacogen; Dacogen

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed de novo or secondary MDS.

2. Age greater than or equal to 18 years.

3. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

4. 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).

5. Life expectancy of at least 6 weeks.

6. If currently receiving 5 day decitabine regimen, patient must be scheduled to receive one more cycle of 5 day decitabine.

7. Recovered from all toxic effects of all prior therapy before entry into this study.

8. 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.

Exclusion Criteria

1. 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.

2. History of treatment failure with decitabine.

3. Received any experimental agent within the preceding 30 days prior to screening.

4. Uncontrolled cardiac or pulmonary disease.

5. History of intestinal surgery, pancreatic surgery, or gastric surgery.

6. 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.

7. 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.

8. 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.

9. Known positive serology for human immunodeficiency virus (HIV).

10. Active viral, fungal, or bacterial infection. No patient may enter the study unless infections have been fully treated.

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

Sponsors

Eisai Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eisai US Medical Services

Role: STUDY_DIRECTOR

Eisai Inc.

Locations

Scottsdale, Arizona, United States

Denver, Colorado, United States

Rochester, Minnesota, United States

The Bronx, New York, United States

Houston, Texas, United States

Tacoma, Washington, United States

Countries

United States

Other Identifiers

E7373-A001-101

Identifier Type: -

Identifier Source: org_study_id