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

• Status: Completed
• Trial end date: 2019-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.

Criteria

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