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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion 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

Exclusion Criteria

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

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Arm 1 		MGCD265 in patients with MET activating mutations in tumor tissue
  • Drug: MGCD265
    MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Experimental
Arm 2 		MGCD265 in patients with MET gene amplifications in tumor tissue
  • Drug: MGCD265
    MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Experimental
Arm 3 		MGCD265 in patients with MET activating mutations in blood (circulating tumor DNA)
  • Drug: MGCD265
    MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
Experimental
Arm 4 		MGCD265 in patients with MET gene amplifications in blood (circulating tumor DNA)
  • Drug: MGCD265
    MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor

More Details

Status
Completed
Sponsor
Mirati Therapeutics Inc.

Study Contact

Detailed Description

If testing has not already been performed, the study will provide for the testing.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.