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

Phase 2CompletedNCT02018926

Mirati Therapeutics Inc.18 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic Syndrome

Interventions

MocetinostatDRUG

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

AzacitidineDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Georegetown University

Washington D.C., District of Columbia, United States

Lakes Research

Miami Lakes, Florida, United States

Mayo Clinic

Rochester, Minnesota, United States

Outcomes

Primary Outcomes

Number of subjects with adverse events, including pericardial events, as a measure of safety

Time frame: 6 months

Secondary Outcomes

Number of subjects experiencing clinical disease response

Time frame: 1 year

Data from ClinicalTrials.gov

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