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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Mirati Therapeutics Inc.
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier:
NCT02805660
First received: June 10, 2016
Last updated: March 28, 2017
Last verified: March 2017
  Purpose

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 Intervention Phase
Advanced Cancer
Drug: mocetinostat
Drug: durvalumab
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Mirati Therapeutics Inc.:

Primary Outcome Measures:
  • Incidence of dose limiting toxicities [ Time Frame: Up to 28 days on combination treatment ]
  • 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:
  • Number of patients experiencing Adverse Events [ Time Frame: Up to 25 weeks ]
  • Blood plasma MGCD0103 concentration [ Time Frame: Up to 25 weeks ]
  • Blood plasma MEDI4736 concentration [ Time Frame: Up to 25 weeks ]

Estimated Enrollment: 119
Study Start Date: May 2016
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02805660

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

Locations
United States, California
David Geffen School of Medicine at UCLA Recruiting
Los Angeles, California, United States, 90095
United States, Illinois
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
United States, Washington
Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Mirati Therapeutics Inc.
  More Information

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02805660     History of Changes
Other Study ID Numbers: 0103-020
Study First Received: June 10, 2016
Last Updated: March 28, 2017

Keywords provided by Mirati Therapeutics Inc.:
MGCD0103
Mocetinostat
MEDI4736
Durvalumab
HDAC Inhibitor
PD-L1 Inhibitor
Phase 1
Phase 2
Metastatic Solid Tumor
Non-small cell lung cancer
immunotherapy
checkpoint inhibitor

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

ClinicalTrials.gov processed this record on April 28, 2017