NCT02018926

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

December 12, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 23, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.8 years

First QC Date

December 12, 2013

Last Update Submit

September 6, 2017

Conditions

Myelodysplastic Syndrome

Keywords

MocetinostatAzacitidineVidazaMyelodysplastic syndromeHDACHMAMDS

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • Number of subjects experiencing clinical disease response

    1 year

Study Arms (1)

Mocetinostat and azacitidine

EXPERIMENTAL

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

Drug: MocetinostatDrug: Azacitidine

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

Also known as: MGCD0103
Mocetinostat and azacitidine
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

Also known as: Vidaza
Mocetinostat and azacitidine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Georegetown University

Washington D.C., District of Columbia, 20057, United States

Location

Lakes Research

Miami Lakes, Florida, 33014, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Norris Cotton Cancer Center, Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

St. Francis Hospital

Greenville, South Carolina, 29601, United States

Location

Cancer Care Centers of South Texas

New Braunfels, Texas, 78130, United States

Location

Cancer Care Centers of South Texas

San Antonio, Texas, 78229, United States

Location

Fletcher Allen Health Care and Vermont Cancer Center

Burlington, Vermont, 05405, United States

Location

MeSH Terms

Conditions

Myelodysplastic Syndromes

Interventions

mocetinostatAzacitidine

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza CompoundsOrganic ChemicalsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Officials

  • Isan Chen, MD

    Mirati Therapeutics Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2013

First Posted

December 23, 2013

Study Start

December 1, 2013

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

September 14, 2017

Record last verified: 2017-09

Locations

US(10)