Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2017 |
| Start Date: | December 2013 |
| End Date: | September 2015 |
A Phase I/II, Multi-Center Study of Mocetinostat (MGCD0103) in Combination With Azacitidine in Subjects With Intermediate or High Risk Myelodysplastic Syndrome (MDS)
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.
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.
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.
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.
Inclusion Criteria:
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.
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.
We found this trial at
10
sites
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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One Medical Center Drive
Lebanon, New Hampshire 03756
Lebanon, New Hampshire 03756
(603) 653-9000
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Norris Cotton Cancer Center at DHMC in...
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New York Medical College The College was founded in 1860 by a group of New...
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Cancer Care Centers of South Texas At Cancer Care Centers of South Texas, we are...
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