A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

Sponsor

Eisai Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00282399

Collaborator

(none)

Enrollment

Locations

Arms

28.1

Duration (Months)

13.7

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndrome	Drug: Subcutaneous Decitabine	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I/II Trial of Subcutaneous Decitabine Maximizing Genomic Demethylation in Patients With Myelodysplastic Syndrome.

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Oct 1, 2008

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: DACO-019 2mg/m^2 DACO-019 2mg/m^2 twice daily (BID)	Drug: Subcutaneous Decitabine
Experimental: DACO-019 5mg/m^2 DACO-019 5mg/m^2 BID	Drug: Subcutaneous Decitabine
Experimental: DACO-019 10mg/m^2 DACO-019 10mg/m^2 BID	Drug: Subcutaneous Decitabine

Arm

Intervention/Treatment

Experimental: DACO-019 2mg/m^2

DACO-019 2mg/m^2 twice daily (BID)

Drug: Subcutaneous Decitabine

Experimental: DACO-019 5mg/m^2

DACO-019 5mg/m^2 BID

Drug: Subcutaneous Decitabine

Experimental: DACO-019 10mg/m^2

DACO-019 10mg/m^2 BID

Drug: Subcutaneous Decitabine

Outcome Measures

Primary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Arizona Cancer Center	Tucson	Arizona	United States	85724
2	H Lee Moffitt Cancer Center & Research Institute	Tampa	Florida	United States	33612
3	Albert Einstein College of Medicine	Bronx	New York	United States	10461