Phase 2 Study of MGCD265 in Patients With Non-Small Cell Lung Cancer With Activating Genetic Alterations in MET
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.
Timeline
- Start
- 2015-10
- Primary completion
- 2018-04-30
- Completion
- 2019-01
Outcome
Missed primary endpoint
registry analysis (superiority test); MET Activating Mutations in Tumor Tissue; p = 0.94; Objective response rate 10.7 (95% CI 2.27 to 28.23); exact test NCT02544633 ↗
registry analysis (superiority test); MET Gene Amplifications in Tumor Tissue; p = 0.79; Objective response rate 15.0 (95% CI 3.21 to 37.89); exact test NCT02544633 ↗
registry analysis (superiority test); MET Activating Mutations in ctDNA; p = 0.47; Objective response rate 25.0 (95% CI 3.19 to 65.09); Exact Test NCT02544633 ↗
registry analysis (superiority test); MET Gene Amplifications in ctDNA; p >0.999; Objective response rate 0 (95% CI 0.00 to 26.46); Exact test NCT02544633 ↗
Publications
- Hong DS, Cappuzzo F, Chul Cho B, Dowlati A, Hussein M, Kim DW, Percent I, Christensen JG, Morin J, Potvin D, Faltaos D, Tassell V, Der-Torossian H, Chao R. Phase II study investigating the efficacy and safety of glesatinib (MGCD265) in patients with advanced NSCLC containing MET activating alterations. Lung Cancer. 2024 Apr;190:107512. doi: 10.1016/j.lungcan.2024.107512. Epub 2024 Feb 22.
- Kollmannsberger C, Hurwitz H, Bazhenova L, Cho BC, Hong D, Park K, Reckamp KL, Sharma S, Der-Torossian H, Christensen JG, Faltaos D, Potvin D, Tassell V, Chao R, Shapiro GI. Phase I Study Evaluating Glesatinib (MGCD265), An Inhibitor of MET and AXL, in Patients with Non-small Cell Lung Cancer and Other Advanced Solid Tumors. Target Oncol. 2023 Jan;18(1):105-118. doi: 10.1007/s11523-022-00931-9. Epub 2022 Dec 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Glesatinib | Small molecule | 750 mg | Oral |
| Subject | Glesatinib | Small molecule | 1050 mg | Oral |