Clinical trial NCT02805660: Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Advanced Cancer
Keywords: MGCD0103
MEDI4736
Mocetinostat
Durvalumab
HDAC Inhibitor
PD-L1 Inhibitor
Phase 1
Phase 2
Metastatic Solid Tumor
Non-small cell lung cancer
immunotherapy
checkpoint inhibitor
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 83
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Participants Who Experience a Dose-Limiting Toxicity (DLT) During the First 28-day Cycle of Combination Treatment In Phase 1
timeFrame: 28 days
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 10 months
Secondary outcomes:
measure: Number of Participants Experiencing Treatment-Emergent Adverse Events
timeFrame: Day 1 to 28 days after last dose of study treatment (up to a maximum of 125 weeks in phase 1 and a maximum of 92 weeks in phase 2)
measure: Duration of Response (DR)
timeFrame: Up to approximately 10 months
measure: Clinical Benefit Rate (CBR)
timeFrame: Up to approximately 10 months
measure: Progression-Free Survival (PFS)
timeFrame: Randomization until progressive disease or death due to any cause (up to 42 months)
measure: 1-Year Survival Rate
timeFrame: 1 year
measure: Overall Survival (OS)
timeFrame: From date of first study treatment until death due to any cause (up to 42 months)
measure: Concentration of Mocetinistat in Blood Plasma
timeFrame: Cycle 1 Day 1 pre-dose, 1, 3, and 7 hours post-dose, Cycle 1 Day 15 pre-dose and 1 hour post-dose, Cycle 2 Day 1 pre-dose and 1 hour post-dose, Cycle 3 Day 1 pre-dose and 1 hour post-dose and Cycle 7 Day 1 pre-dose (each cycle is 28 days)
measure: Concentration of Durvalumab in Blood Plasma
timeFrame: Cycle 1 Day 1 pre-dose + end of infusion, Cycle 1 Day 15 pre-mocetinostat dose, Cycle 2 Day 1 pre-dose, Cycle 3 Day 1 pre-dose, Cycle 4 Day 1 pre-dose + end of infusion, Cycle 7 Day 1 pre-dose + 90 days after participant's last dose (Up to max 133 weeks)
measure: Number of Participants With the Presence of Anti-Drug Antibody (ADA) in the Blood
timeFrame: Up to approximately 10 months
measure: Number of Participants With Tumor Expression of Programmed Cell Death Ligand 1 (PD-L1) at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Southern Cancer Center, PC
state: Alabama
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Pensacola
country: United States
facility: Woodlands Medical Specialists - Pensacola
state: Florida
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center of Northwestern University
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Minneapolis
country: United States
facility: Unniversity of Minnesota Masonic Cancer Center
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas
country: United States
facility: Mary Crowley Cancer Research Centers
state: Texas
city: Denton
country: United States
facility: Texas Oncology - Denton South
state: Texas
city: Plano
country: United States
facility: Texas Oncology-Plano West
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology - Winchester
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance
state: Washington
Study officials:
References: