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Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC

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ClinicalTrials.gov Identifier: NCT02805660
Recruitment Status : Recruiting
First Posted : June 20, 2016
Last Update Posted : December 8, 2017
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:

Mocetinostat (MGCD0103) is an orally administered HDAC inhibitor. Durvalumab (MEDI4736) is a human monoclonal antibody that is an inhibitor of the Programmed Cell Death Ligand (or PD-L1). Durvalumab is also known as a checkpoint inhibitor.

This study is evaluating the combination regimen of mocetinostat and durvalumab in subjects with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.

Patients eligible for this study may have previously received treatment with a checkpoint inhibitor.

Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: mocetinostat Drug: durvalumab Phase 1 Phase 2

Detailed Description:
The treatment regimen will begin with a 7-Day Lead-in Period of mocetinostat alone followed by start of the combination regimen of mocetinostat and durvalumab. The Recommended Phase 2 Dose of mocetinostat will be established in the Phase 1 dose escalation segment, followed by evaluation of the clinical activity of the combination regimen in Phase 2.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 119 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 Study of HDAC Inhibitor, Mocetinostat, in Combination With PD-L1 Inhibitor, Durvalumab, in Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer
Actual Study Start Date : May 2016
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Durvalumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Mocetinostat and Durvalumab
Mocetinostat oral capsules, three times weekly along with durvalumab intravenously administered in 28 day cycles
Drug: mocetinostat
Mocetinostat oral capsule, administered three times weekly in combination with durvalumab
Other Name: MGCD0103
Drug: durvalumab
Durvalumab 1500mg intravenously administered in 28 day cycles in combination with mocetinostat
Other Name: MEDI4736

Primary Outcome Measures :
  1. Incidence of dose limiting toxicities [ Time Frame: Up to 28 days on combination treatment ]
  2. Number of patients experiencing tumor size reduction [ Time Frame: Up to one year ]
    Tumors will be measured using radiographic scans. Tumor size reduction and overall disease response will be categorized according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Secondary Outcome Measures :
  1. Number of patients experiencing Adverse Events [ Time Frame: Up to 25 weeks ]
  2. Blood plasma MGCD0103 concentration [ Time Frame: Up to 25 weeks ]
  3. Blood plasma MEDI4736 concentration [ Time Frame: Up to 25 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Phase 1-Diagnosis of advanced or metastatic solid tumor; Phase 2-Diagnosis of NSCLC
  • Not amenable to treatment with curative intent
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • Impaired heart function
  • Uncontrolled tumor in the brain
  • Other active cancer

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02805660

Contact: Mirati Therapeutics Study Locator Services Emergingmed 1-844-356-0895 (toll-free) miratistudylocator@emergingmed.com

United States, Alabama
Southern Cancer Center, PC Recruiting
Mobile, Alabama, United States, 36608
United States, California
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
United States, Florida
Woodlands Medical Specialists - Pensacola Recruiting
Pensacola, Florida, United States, 32503
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center of Northwestern University Recruiting
Chicago, Illinois, United States, 60611
NorthShore University Health System Recruiting
Evanston, Illinois, United States, 60201
United States, Minnesota
Unniversity of Minnesota Masonic Cancer Center Recruiting
Minneapolis, Minnesota, United States, 55414
United States, New Jersey
Hackensack University Medical Center Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Mary Crowley Cancer Research Centers Recruiting
Dallas, Texas, United States, 75230
Texas Oncology - Denton South Recruiting
Denton, Texas, United States, 76210
Texas Oncology-Plano West Recruiting
Plano, Texas, United States, 75093
United States, Virginia
Virginia Cancer Specialists Recruiting
Fairfax, Virginia, United States, 22031
Shenandoah Oncology - Winchester Recruiting
Winchester, Virginia, United States, 22601
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Mirati Therapeutics Inc.

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02805660     History of Changes
Other Study ID Numbers: 0103-020
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017

Keywords provided by Mirati Therapeutics Inc.:
HDAC Inhibitor
PD-L1 Inhibitor
Phase 1
Phase 2
Metastatic Solid Tumor
Non-small cell lung cancer
checkpoint inhibitor

Additional relevant MeSH terms:
Antibodies, Monoclonal
Histone Deacetylase Inhibitors
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action