A Study of Decitabine Given Subcutaneously to Adults With Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

September 18, 2013 updated by: Eisai Inc.

Randomized Open-label Phase 2 Study of Low Dose Dacogen® for Injection (Decitabine) in Patients With Low or Intermediate 1 Risk Myelodysplastic Syndromes

The purpose of this study is to determine the effectiveness and safety of two different dose schedules of DACOGEN® (decitabine) for Injection in patients with Myelodysplastic Syndromes (MDS).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized open-label Phase 2 efficacy and safety study of two (2) subcutaneous (SQ) dosing schedules of decitabine in subjects with Low or Intermediate 1 Risk MDS. This study will be conducted in up to 6 study centers in the United States.

The primary efficacy outcome is the overall improvement rate. These two doses will be administered subcutaneously. The probability that one schedule is superior to the other will be estimated, and the level of toxicity for each schedule will also be evaluated.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
    • Rhode Island
      • Woonsocket, Rhode Island, United States, 02895
        • Landmark Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research
    • Texas
      • Houston, Texas, United States, 77030
        • M. D. Anderson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Each patient must meet the following criteria to be enrolled in this study:

  1. Male or female patients age 18 years and older.
  2. Patients must sign an institutional review board (IRB)-approved informed consent form, and understand the investigational nature of this study and its potential hazards prior to initiation of any study-specific procedures or treatment.
  3. Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
  4. Adequate renal and hepatic function (creatinine < 2 times upper limit of normal, total bilirubin of < 2 times upper limit of normal, and AST and ALT ≤ 2 times upper limit of normal) unless proven to be related to disease infiltration.
  5. Female patients need a negative serum or urine pregnancy test within 7 days prior to study drug administration (applies only if patient is of childbearing potential. Non-childbearing is defined as ≥ 1 year postmenopausal or surgically sterilized).
  6. Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study.
  7. Patients with Low or Intermediate-1 Risk MDS by the International Prognostic Scoring System (IPSS) classification.

Exclusion Criteria:

Patients who meet any of the following criteria will be excluded from the study:

  1. Women who are pregnant or nursing.
  2. Those who have received prior therapy with decitabine.
  3. Prior therapy with azacitidine (Vidaza®).
  4. Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
  5. Those who have received an investigational agent 30 days prior to the first dose of decitabine.
  6. Patients with active, uncontrolled, systemic infection considered opportunistic, life threatening or clinically significant; or any severe, concurrent disease, which, in the judgment of the Investigator and after discussion with the Sponsor and Primary Investigator, would make the patient inappropriate for study entry.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: decitabine
Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
Other Names:
  • Dacogen
Drug: decitabine
Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
Other Names:
  • Dacogen
Experimental: 2
Drug: decitabine
Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
Other Names:
  • Dacogen
Drug: decitabine
Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
Other Names:
  • Dacogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Overall Improvement Rate
Time Frame: Up to one year

Defined as proportion of patients having complete remission (CR), partial remission (PR), marrow complete remission (mCR), or hematologic improvement.

Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes.

Complete Remission: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 109/L; Neutrophils ≥ 1.0 X 109/Lb; Blasts 0%.

Partial Remission: All CR criteria if abnormal before treatment except: Bone marrow blasts decreased by ≥ 50% over pretreatment but still > 5%.

Marrow Complete Remission: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement responses, they will be noted in addition to marrow CR.

HI Improvement: shown in increases in hemoglobin, platelet and neutrophil response.
Up to one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

February 8, 2008

First Submitted That Met QC Criteria

February 19, 2008

First Posted (Estimate)

February 20, 2008

Study Record Updates

Last Update Posted (Estimate)

October 24, 2013

Last Update Submitted That Met QC Criteria

September 18, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DACO-026

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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