NCT02219711

Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 193 (actual)
• Sponsor: Mirati Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles. During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Detailed description

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed. During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis: Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL. Head and neck squamous cell carcinoma with genetic alterations in MET. Clear cell renal cell carcinoma refractory to angiogenesis inhibitors. Metastatic prostate cancer with bone metastases. Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Conditions

• Advanced Cancer

Interventions

Type	Name	Description
DRUG	MGCD516	MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.

Timeline

• Start date: 2014-08-01
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2014-08-19
• Last updated: 2023-03-06

Locations

43 sites across 2 countries: United States, South Korea