Print

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 participants with Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Phase 1: Dose Escalation - 50 mg 		The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
  • Drug: Mocetinostat - 50 mg
    Participants received mocetinostat three times weekly as an oral capsule.
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736
Experimental
Phase 1: Dose Escalation - 70 mg 		The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
  • Drug: Mocetinostat - 70 mg
    Participants received mocetinostat three times weekly as an oral capsule.
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736
Experimental
Phase 1: Dose Escalation - 90 mg 		The Phase 1 dose escalation established the recommended phase 2 dose (RP2D) of mocetinostat. Participants with advanced solid tumors were included in this Phase.
  • Drug: Mocetinostat - 90 mg
    Participants received mocetinostat three times weekly as an oral capsule.
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736
Experimental
Phase 2: Combination Regimen - Cohort 1 		Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with no/low programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
  • Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)
    Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736
Experimental
Phase 2: Combination Regimen - Cohort 2 		Participants with non-small cell lung cancer (NSCLC) who were naïve to treatment with immunotherapy, and had a tumor with high programmed cell death ligand 1 (PD-L1) expression were included in this cohort.
  • Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)
    Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736
Experimental
Phase 2: Combination Regimen - Cohort 3 		Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent with clinical benefit response followed by progression of disease were included in this cohort.
  • Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)
    Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736
Experimental
Phase 2: Combination Regimen - Cohort 4 		Participants with non-small cell lung cancer (NSCLC) who have been previously treated with an anti-programmed cell death ligand 1 (PD-L1) or anti-programmed cell death 1 (PD-1) agent who had progression of disease ≤ 16 weeks after initiation of treatment were included in this cohort.
  • Drug: Mocetinostat - Recommended Phase 2 Dose (70 mg)
    Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
    Other names:
    • MGCD0103
  • Drug: Durvalumab - 1500 mg
    Participants received durvalumab as an intravenous infusion every 4 weeks.
    Other names:
    • MEDI4736

More Details

Status
Terminated
Sponsor
Mirati Therapeutics Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.