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 Details — Status: Completed

Administrative data

• NCT number: NCT02018926
• Other study ID #: 0103-014
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 12, 2013
• Last updated: August 30, 2017
• Start date: December 2013
• Est. completion date: September 2015

Study information

• Verified date: August 2017
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• Mocetinostat
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
• Azacitidine
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

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care and Vermont Cancer Center	Burlington	Vermont
United States	Duke University Medical Center	Durham	North Carolina
United States	St. Francis Hospital	Greenville	South Carolina
United States	Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Lakes Research	Miami Lakes	Florida
United States	Cancer Care Centers of South Texas	New Braunfels	Texas
United States	Mayo Clinic	Rochester	Minnesota
United States	Cancer Care Centers of South Texas	San Antonio	Texas
United States	New York Medical College	Valhalla	New York
United States	Georegetown University	Washington, D.C.	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events, including pericardial events, as a measure of safety		6 months
Secondary	Number of subjects experiencing clinical disease response		1 year