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

Phase 1
18 Years
Open (Enrolling)
Myelodysplastic Syndrome

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Trial Information

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

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.

Inclusion Criteria:

1. Histologically confirmed de novo or secondary MDS.

2. Age ≥ 18 years.

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

4. Adequate renal and hepatic function (creatinine ≤ 2.0 mg/dL, total bilirubin < 2.0
mg/dL, aspartate aminotransferase [AST] or alanine aminotransferase [ALT] < 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 (< 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

Eisai US Medical Services

Investigator Role:

Study Director

Investigator Affiliation:

Eisai Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

Related Keywords:

  • Myelodysplastic Syndrome
  • MDS
  • Myelodysplastic Syndromes
  • Preleukemia



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