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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Eisai Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00941109
First received: July 15, 2009
Last updated: April 4, 2012
Last verified: April 2012

July 15, 2009
April 4, 2012
September 2009
December 2010   (final data collection date for primary outcome measure)
Pharmacokinetic (PK) endpoints will be decitabine PK parameters: Tmax, Cmax, AUC0-inf, t1/2 and F. [ Time Frame: Cycle 1 on Days 1 & 2 from predose up to 6 hours after administration. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00941109 on ClinicalTrials.gov Archive Site
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. [ Time Frame: Up to 30 days after the last dose of decitabine. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Escalation Study to Determine Bioavailability of a Single Oral Dose of Decitabine in Patients With Myelodysplastic Syndrome (MDS)
A Dose Escalation Study to Determine the Absolute Bioavailability of a Single Oral Dose Administration of Decitabine in Patients With Myelodysplastic Syndrome (MDS)

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Myelodysplastic Syndrome
  • Drug: 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.
    Other Name: Dacogen
  • 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.
    Other Name: Dacogen
  • 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.
    Other Name: Dacogen
  • 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.
    Other Name: Dacogen
  • Experimental: 1
    Intervention: Drug: decitabine
  • Experimental: 2
    Intervention: Drug: decitabine
  • Experimental: 3
    Intervention: Drug: decitabine
  • Experimental: 4
    Intervention: Drug: decitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
Not Provided
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00941109
E7373-A001-101
No
Eisai Inc.
Eisai Inc.
Not Provided
Study Director: Eisai US Medical Services Eisai Inc.
Eisai Inc.
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP