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NSCLC 265-109


Title Phase 2, Parallel-Arm Study of MGCD265 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with Activating Genetic Alterations in Mesenchymal- Epithelial Transition Factor
Therapeutic Area Lung Cancer, Non Small Cell Lung Cancer
Principal Investigator Lori Pai, MD
Min Age 18 Years
Gender Both
Contact Madeleine Arthur
617-636-2616
More Information https://clinicaltrials.gov/ct2/show/NCT02544633

Overview

The main purpose of this study is to test whether subjects with lung cancer, with specific changes in the tumor genes, benefit from getting study drug, MGCD265.  Other objectives of the study include assessing the side effects of MGCD265 in subjects, and how much and how quickly drug is absorbed and cleared from the blood stream.

Study Details

Inclusion Criteria

  • Diagnosis of non-small cell lung cancer
  • Metastatic or locally advanced disease
  • Test result showing genetic change in MET tumor gene
  • Prior chemotherapy

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 Requirements

This study will be carried in four groups of subjects based on the kind of changes identified in tumor genes. The tumor genes would be identified either in the tumor tissue or blood by a tumor gene test. MGCD265 will be administered orally, twice daily. During study participation, subjects will have physical exams, bloods draws, CT or MRI scans, EKGs, and other study procedures as required per protocol.