Phase 1/2 Study of Mocetinostat and Durvalumab in Patients With Advanced Solid Tumors and NSCLC
NCT ID: NCT02805660
Last Updated: 2021-04-06
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE1/PHASE2
83 participants
INTERVENTIONAL
2016-06-01
2019-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer
NCT05903092
Study of Durvalumab or Durvalumab Plus Chemotherapy in Kras Mutation Positive and PD-L1 High (≥ 50%) NSCLC Patients
NCT04470674
Phase 1 Study of M9466 Combined With Carboplatin and Platinum-based Anticancer Therapy (DDRiver 521)
NCT06719973
Phase 2 Study of Glesatinib, Sitravatinib or Mocetinostat in Combination With Nivolumab in Non-Small Cell Lung Cancer
NCT02954991
Combination of Durvalumab and Tremelimumab as Maintenance Treatment in Patients With Non Squamous and Squamous (NSCLC)
NCT03319316
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Mocetinostat - 50 mg
Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
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.
Mocetinostat - 70 mg
Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
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.
Mocetinostat - 90 mg
Participants received mocetinostat three times weekly as an oral capsule.
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
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.
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).
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
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.
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).
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
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.
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).
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
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.
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).
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mocetinostat - 50 mg
Participants received mocetinostat three times weekly as an oral capsule.
Mocetinostat - 70 mg
Participants received mocetinostat three times weekly as an oral capsule.
Mocetinostat - 90 mg
Participants received mocetinostat three times weekly as an oral capsule.
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).
Durvalumab - 1500 mg
Participants received durvalumab as an intravenous infusion every 4 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Not amenable to treatment with curative intent
* Adequate bone marrow and organ function
Exclusion Criteria
* Uncontrolled tumor in the brain
* Other active cancer
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Southern Cancer Center, PC
Mobile, Alabama, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Woodlands Medical Specialists - Pensacola
Pensacola, Florida, United States
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
Chicago, Illinois, United States
NorthShore University Health System
Evanston, Illinois, United States
Unniversity of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Montefiore Medical Center
The Bronx, New York, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Mary Crowley Cancer Research Centers
Dallas, Texas, United States
Texas Oncology - Denton South
Denton, Texas, United States
Texas Oncology-Plano West
Plano, Texas, United States
Virginia Cancer Specialists
Fairfax, Virginia, United States
Shenandoah Oncology - Winchester
Winchester, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0103-020
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.