NCT00282399

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2006

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 26, 2006

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

October 28, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

January 25, 2006

Last Update Submit

October 27, 2015

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic SyndromeMGI PharmaDecitabineDacogen

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (3)

DACO-019 2mg/m^2

EXPERIMENTAL

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

Drug: Subcutaneous Decitabine

DACO-019 5mg/m^2

EXPERIMENTAL

DACO-019 5mg/m\^2 BID

Drug: Subcutaneous Decitabine

DACO-019 10mg/m^2

EXPERIMENTAL

DACO-019 10mg/m\^2 BID

Drug: Subcutaneous Decitabine

Interventions

Subcutaneous DecitabineDRUG
DACO-019 10mg/m^2DACO-019 2mg/m^2DACO-019 5mg/m^2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Arizona Cancer Center

Tucson, Arizona, 85724, United States

Location

H Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Links

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2006

First Posted

January 26, 2006

Study Start

October 1, 2006

Primary Completion

October 1, 2008

Study Completion

February 1, 2009

Last Updated

October 28, 2015

Record last verified: 2015-10

Locations

US(3)