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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Mirati Therapeutics Inc.
Study ID
NCT02805660
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mocetinostat - 50 mg — DRUG
    Participants received mocetinostat three times weekly as an oral capsule.
  • Mocetinostat - 70 mg — DRUG
    Participants received mocetinostat three times weekly as an oral capsule.
  • Mocetinostat - 90 mg — DRUG
    Participants received mocetinostat three times weekly as an oral capsule.
  • Mocetinostat - Recommended Phase 2 Dose (70 mg) — DRUG
    Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
  • Durvalumab - 1500 mg — DRUG
    Participants received durvalumab as an intravenous infusion every 4 weeks.

Study Details

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.

Key Dates

Start date
Jun 1, 2016
Status verified
Mar 2021
Primary completion
Dec 14, 2019
Completion
Dec 20, 2019

Study Design

Enrollment
83 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1 [ Time Frame: 28 days ]

Locations (15)

FacilityCityStateZIPSite coordinators
Southern Cancer Center, PCMobileAlabama36608-
David Geffen School of Medicine at UCLALos AngelesCalifornia90095-
Woodlands Medical Specialists - PensacolaPensacolaFlorida32503-
Robert H. Lurie Comprehensive Cancer Center of Northwestern UniversityChicagoIllinois60611-
NorthShore University Health SystemEvanstonIllinois60201-
Unniversity of Minnesota Masonic Cancer CenterMinneapolisMinnesota55414-
Hackensack University Medical CenterHackensackNew Jersey07601-
Montefiore Medical CenterThe BronxNew York10461-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Mary Crowley Cancer Research CentersDallasTexas75230-
Texas Oncology - Denton SouthDentonTexas76210-
Texas Oncology-Plano WestPlanoTexas75093-
Virginia Cancer SpecialistsFairfaxVirginia22031-
Shenandoah Oncology - WinchesterWinchesterVirginia22601-
Seattle Cancer Care AllianceSeattleWashington98109-

Find similar trials in Mobile, AL

By research site
Southern Cancer Center, PC· Mobile, ALDavid Geffen School of Medicine at UCLA· Los Angeles, CAWoodlands Medical Specialists - Pensacola· Pensacola, FLRobert H. Lurie Comprehensive Cancer Center of Northwestern University· Chicago, ILNorthShore University Health System· Evanston, ILUnniversity of Minnesota Masonic Cancer Center· Minneapolis, MN

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