Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Advanced Cancer MGCD0103 MEDI4736 Mocetinostat Durvalumab HDAC Inhibitor PD-L1 Inhibitor Phase 1 Phase 2 Metastatic Solid Tumor Non-small cell lung cancer immunotherapy checkpoint inhibitor Antibodies, Monoclonal Histone Deacetylase Inhibitors Mocetinostat and Durvalumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

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

Locations

  • David Geffen School of Medicine at UCLA
    Los Angeles California 90095 United States
  • Seattle Cancer Care Alliance
    Seattle Washington 98109 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
ID
NCT02805660
Phase
Phase 1/2
Study Type
Interventional
Last Updated