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

NCT02805660 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2021-04-06

Study results available
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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.

Conditions

Interventions

DRUG

Mocetinostat - 50 mg

Participants received mocetinostat three times weekly as an oral capsule.

DRUG

Mocetinostat - 70 mg

Participants received mocetinostat three times weekly as an oral capsule.

DRUG

Mocetinostat - 90 mg

Participants received mocetinostat three times weekly as an oral capsule.

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).

DRUG

Durvalumab - 1500 mg

Participants received durvalumab as an intravenous infusion every 4 weeks.

Sponsors & Collaborators

  • Mirati Therapeutics Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-01
Primary Completion
2019-12-14
Completion
2019-12-20

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02805660 on ClinicalTrials.gov