NCT02544633

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	MGCD265	MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor

Timeline

• Start date: 2015-10-01
• Primary completion: 2018-04-30
• Completion: 2019-01-01
• First posted: 2015-09-09
• Last updated: 2020-03-04
• Results posted: 2019-09-10

Locations

94 sites across 9 countries: United States, Australia, Canada, Hungary, Italy, Poland, South Korea, Taiwan, United Kingdom