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Clinical Trial Detail

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

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

Research Study Number 20150094
Principal Investigator Keith Eaton, MD, PhD
Phase I

Research Study Description

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, or selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Eligibility Criteria (must meet the following to participate in this study)

** For Eligibility information, please click on the "Look up trial at NIH" link above. **

Other eligibility criteria may apply.

Research Study Number 20150094
Contact Seattle Cancer Care Alliance Intake Office
Telephone 800-804-8824 / 206-606-1024

Keywords: Head and Neck Cancer; Lung Cancer; Prostate Cancer; Solid Tumors; Neoplasms; Lung Carcinoma, Non-Small-Cell (NSCLC)

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