A Phase I, Multi-Center, Single-Arm, Open-Label Study of Mocetinostat (MGCD0103) in Combination With Azacitidine in Subjects With Intermediate or High Risk Myelodysplastic Syndrome (MDS)

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

Mocetinostat is an orally administered histone deacetylase (HDAC) inhibitor. Azacitidine is a hypomethylating agent (HMA) used to treat MDS. In this study, patients with intermediate- or high-risk MDS will receive treatment with mocetinostat and azacitidine to evaluate the safety of the study treatment. Safety assessments will include echocardiograms, electrocardiograms and routine safety laboratory studies (hematology and serum chemistry). In addition, clinical response to treatment will be monitored using bone marrow aspirates or biopsies, and other routine methods.

Who is eligible to participate?

Inclusion Criteria: Diagnosis of intermediate- or high-risk (IPSS criteria) myelodysplastic syndrome. Any prior treatment, including no prior treatment. ECOG Performance Status 0 or 1. Exclusion Criteria: Current or history of small, moderate or large pericardial effusion, tamponade and/or pericarditis. Significant cardiac abnormalities such as recent myocardial infarction, congestive heart failure ≥ Class 3, or symptomatic, uncontrolled atrial fibrillation, atrial flutter or sinus tachycardia. Prolonged QT/QTc interval. Other active cancer excluding basal cell carcinoma or cervical intraepithelial neoplasia.

Last updated:

2/14/2014

NCT ID:

NCT02018926

IRB Number:

13-006053