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Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS

Myelodysplastic Syndrome Clinical Trial

Official title:
A Phase I/II, Multi-Center Study of Mocetinostat (MGCD0103) in Combination With Azacitidine in Subjects With Intermediate or High Risk Myelodysplastic Syndrome (MDS)

Clinical Trial Summary

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.

Clinical Trial Description

The study will include multiple cohorts of patients. In the first cohort, patients may have previously received treatment with hypomethylating agents such as azacitidine. In later cohorts, prior treatment with this class of anti-cancer agents will be excluded. Later cohorts will include patients that are receiving this class of agents, specifically azacitidine, for the first time. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02018926
Study type Interventional
Source Mirati Therapeutics Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date December 2013
Completion date September 2015
View Details
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