A Clinical Trial of Decitabine in Patients With Myelodysplastic Syndrome

Eisai

Status and phase: Terminated; Phase 1

Conditions: Myelodysplastic Syndrome

Treatments: Drug: Subcutaneous Decitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00282399

DACO-019

Details and patient eligibility

About

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

Full 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

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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41 participants in 3 patient groups

DACO-019 2mg/m^2

Experimental group

Description:

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

Treatment:

Drug: Subcutaneous Decitabine

DACO-019 5mg/m^2

Experimental group

Description:

DACO-019 5mg/m\^2 BID

Treatment:

Drug: Subcutaneous Decitabine

DACO-019 10mg/m^2

Experimental group

Description:

DACO-019 10mg/m\^2 BID

Treatment:

Drug: Subcutaneous Decitabine