Oral Targeted Therapy MGCD265 in NSCLC
This study is a phase 2 trial of the drug 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. Ideally testing will be done while in current treatment. Patients must have previously received treatment with chemotherapy. 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.
In order to participate you must meet the following criteria:
- Have histologically confirmed NSLC with metastatic or unresectable, locally advanced disease.
- Receipt of at least one prior treatment regimen in the advanced disease setting.
- Have genetic alteration activating MET in tumor tissue and/or ctDNA (local testing may be used, but central laboratory confirmation may be necessary).
- Have an ECOG performance status 0-2.
You will be excluded from the study if any of the following criteria apply to you:
- Have had prior treatment with a small molecule or antibody inhibitor of MET or HGF.
- Have had prior positive test for EGFR mutation or ALK gene rearrangement.
- Have a history of stroke or transient ischemic attack within the previous 6 months.
- Have cardiac abnormalities (unstable angina pectoris, CHF, or QTc > 480 msec).
- Have known or suspected secondary malignancy.
- Have symptomatic or uncontrolled brain metastases requiring current treatment.
- Have pre-existing gastrointestinal disorders.
This is a partial list of inclusion and exclusion criteria.