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

NCT00619099 | Completed Phase 2 Results

• 1 other identifier: DACO-026
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 4

Brief Summary

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).

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; Decitabine; Dacogen; MGI PHARMA, Inc.

Outcome Measures

Primary Outcomes (1)

• The Overall Improvement Rate

  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

Study Arms (2)

1

EXPERIMENTAL

Drug: decitabine

2

EXPERIMENTAL

Drug: decitabine

Interventions

decitabine DRUG

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.

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:

• Each patient must meet the following criteria to be enrolled in this study:
• Male or female patients age 18 years and older.
• 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.
• Must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• 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.
• 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).
• Women of childbearing potential and men must use contraception. Men and women must continue birth control for the duration of the study.
• Patients with Low or Intermediate-1 Risk MDS by the International Prognostic Scoring System (IPSS) classification.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Women who are pregnant or nursing.
• Those who have received prior therapy with decitabine.
• Prior therapy with azacitidine (Vidaza®).
• Those who received growth factor support or lenalidomide in the 30 days prior to the first dose of decitabine.
• Those who have received an investigational agent 30 days prior to the first dose of decitabine.
• 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.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (4)

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Landmark Medical Center

Woonsocket, Rhode Island, 02895, United States

Location

Sarah Cannon Research

Nashville, Tennessee, 37203, United States

Location

M. D. Anderson

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Garcia-Manero G, Jabbour E, Borthakur G, Faderl S, Estrov Z, Yang H, Maddipoti S, Godley LA, Gabrail N, Berdeja JG, Nadeem A, Kassalow L, Kantarjian H. Randomized open-label phase II study of decitabine in patients with low- or intermediate-risk myelodysplastic syndromes. J Clin Oncol. 2013 Jul 10;31(20):2548-53. doi: 10.1200/JCO.2012.44.6823. Epub 2013 Jun 3.

  PMID: 23733767 DERIVED

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

Results Point of Contact

• Title: Erhan Berrack, M.D.
• Organization: Eisai Inc.

888-422-4743

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2008
• First Posted: February 20, 2008
• Study Start: May 1, 2008
• Primary Completion: March 1, 2012
• Last Updated: October 24, 2013
• Results First Posted: September 18, 2013

Record last verified: 2013-09

Locations

US (4)