Safety Study of Mocetinostat in Combination With Azacitidine in Subjects With MDS
- Registration Number
- NCT02018926
- Lead Sponsor
- Mirati Therapeutics Inc.
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mocetinostat and azacitidine Azacitidine Drug: Mocetinostat (MGCD0103) Mocetinostat (a histone deacetylase \[HDAC\] inhibitor) 70 mg or 90 mg dose, oral capsules 3 times weekly beginning on day 5 for 10 doses in each 28 day cycle Drug: Azacitidine (Vidaza) Azacitidine (a hypomethylating agent \[HMA\]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle Mocetinostat and azacitidine Mocetinostat Drug: Mocetinostat (MGCD0103) Mocetinostat (a histone deacetylase \[HDAC\] inhibitor) 70 mg or 90 mg dose, oral capsules 3 times weekly beginning on day 5 for 10 doses in each 28 day cycle Drug: Azacitidine (Vidaza) Azacitidine (a hypomethylating agent \[HMA\]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle
- Primary Outcome Measures
Name Time Method Number of subjects with adverse events, including pericardial events, as a measure of safety 6 months
- Secondary Outcome Measures
Name Time Method Number of subjects experiencing clinical disease response 1 year
Trial Locations
- Locations (9)
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
🇺🇸San Antonio, Texas, United States
Fletcher Allen Health Care and Vermont Cancer Center
🇺🇸Burlington, Vermont, United States
Georegetown University🇺🇸Washington, D.C., District of Columbia, United States