Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
Completed · Phase 1/Phase 2
Conditions studied: Myelodysplastic Syndrome
In brief
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.
Key facts
- Study ID
- NCT02018926
- Run by
- Mirati Therapeutics Inc.
- People needed
- 18
- Starts
- 2013-12-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2017-09-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of intermediate- or high-risk (IPSS criteria) myelodysplastic syndrome.
- Cohort 1: Any prior treatment, enrollment complete. Cohort 2: Limited or no prior treatment for MDS. Prior treatment should not include hypomethylating agents such as azacitidine or decitabine, or HDAC inhibitors.
- ECOG Performance Status 0 or 1.
You may not qualify if…
- 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.
Where it is running
- Georegetown University — Washington D.C., District of Columbia, United States
- Lakes Research — Miami Lakes, Florida, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
- New York Medical College — Valhalla, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- St. Francis Hospital — Greenville, South Carolina, United States
- Cancer Care Centers of South Texas — New Braunfels, Texas, United States
- Cancer Care Centers of South Texas — San Antonio, Texas, United States
- Fletcher Allen Health Care and Vermont Cancer Center — Burlington, Vermont, United States
Full record on ClinicalTrials.gov
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