Last updated on October 2014

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


Brief description of study

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

Detailed 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 the following cancer diagnosis:

  • Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA or KIT.
  • 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.

Clinical Study Identifier: TX139280

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Recruitment Status: Open


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