A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

Phase 1

Terminated

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: Subcutaneous Decitabine

• Registration Number: NCT00282399
• Lead Sponsor: Eisai Inc.

Brief Summary

The purpose of this study was to determine which of the doses of decitabine maximizes genomic demethylation in patients with Myelodysplastic Syndrome (MDS).

Detailed Description

Phase I: The purpose of this study was to determine which of the subcutaneous doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS

Phase II: To evaluate hematological responses at the dose selected in the Phase I portion of the study.

Note: This study was planned as Phase 1/2 study but only the Phase 1 part was conducted due to a change in product development strategy

Study Timeline

• Study First Submitted: 2006-01-25
• Study First Submitted QC: 2006-01-25
• Study First Posted: 2006-01-26
• Study Start: 2006-10
• Primary Completion: 2008-10
• Study Completion: 2009-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

1. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
2. Confirmed diagnosis of MDS or non-proliferative chronic myelomonocytic leukemia (CMML).

Exclusion Criteria

1. Prior therapy with decitabine or azacytidine (Vidaza).
2. Experimental or standard drugs for the treatment of MDS within 28 days of the first day of study drug treatment.
3. Clinically significant anemia.
4. Prior history of malignancy other than MDS.
5. Any active infection.
6. Radiotherapy within 14 days prior to study enrollment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DACO-019 2mg/m^2	Subcutaneous Decitabine	DACO-019 2mg/m\^2 twice daily (BID)
DACO-019 5mg/m^2	Subcutaneous Decitabine	DACO-019 5mg/m\^2 BID
DACO-019 10mg/m^2	Subcutaneous Decitabine	DACO-019 10mg/m\^2 BID

Primary Outcome Measures

Name	Time	Method
Phase I: To determine which of the subcutaneous (SQ) doses of decitabine administered twice daily for 5 days maximizes genomic demethylation in patients with MDS.	Up to 8 cycles (224 days)
Phase II: To evaluate hematological response at the dose selected in the Phase I portion of the study.	Up to 12 cycles (336 days)

Trial Locations

Locations (3)

H Lee Moffitt Cancer Center & Research Institute; 🇺🇸 Tampa, Florida, United States

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

University of Arizona Cancer Center; 🇺🇸 Tucson, Arizona, United States