Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET

Study summary

MGCD265 is an orally administered receptor tyrosine kinase inhibitor that targets MET and other receptors. This study is a Phase 2 trial of MGCD265 in patients with locally advanced, unresectable or metastatic non-small cell lung cancer (NSCLC) that has activating genetic changes of the MET gene (mutation or amplification \[increase number of gene copies\]). Testing for tumor gene changes can be performed in tumor tissue or blood samples. Patients must have previously received treatment with chemotherapy. The number of patients to be enrolled will depend on how many enrolled patients experience tumor size reduction. MGCD265 will be administered orally, twice daily. The study is designed to evaluate whether the number of patients experiencing tumor size reduction is substantially higher than would be expected with other available treatments.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMGCD265

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · MET · Early-stage or resectable

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Mar 4, 2020 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?94 U.S. locations

Locations may change over time.

Who runs it?Mirati Therapeutics Inc.

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 2
Sponsor: Mirati Therapeutics Inc.
Interventions being studied: Drug: MGCD265

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→Metastatic or stage IV→

Biomarkers

MET→

Treatment approach

Targeted therapy→Chemotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Diagnosis of non-small cell lung cancer
Metastatic or locally advanced disease
Prior platinum chemotherapy or immunotherapy
Test result showing genetic change in MET tumor gene
At least one tumor that can be measured on a radiographic scan

Reasons someone may not be able to joinExclusion criteria

Prior treatment with inhibitor of MET or HGF
Prior positive test for EGFR mutation or ALK gene rearrangement
Uncontrolled tumor in the brain

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

University of Alabama at BirminghamBirmingham, Alabama
Clearview Cancer InstituteHuntsville, Alabama
Fowler Family Center for Cancer CareJonesboro, Arkansas
Providence Saint Joseph Medical CenterBurbank, California
Saint Joseph Heritage HealthcareFullerton, California
University of California San DiegoLa Jolla, California
Loma Linda University Medical CenterLoma Linda, California
University of California, San FranciscoSan Francisco, California
Innovative Clinical Reseach InstituteWhittier, California
St. Mary's Regional Cancer CenterGrand Junction, Colorado
Eastern Connecticut Hematology and Oncology AssociatesNorwich, Connecticut
Georgetown University Medical CenterWashington D.C., District of Columbia

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 4, 2020. Always confirm current availability with the study team.

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