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Brief Title: INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
Official Title: Phase Ib Study Evaluating the c-Met Inhibitor INC280 in Combination With Bevacizumab in Patients With Glioblastoma Multiforme (GBM)
Study ID: NCT02386826
Brief Summary: The purpose of this study is to determine whether the combination of two agents, INC280 and bevacizumab, is safe and effective when administered to patients with Glioblastoma Multiforme (GBM) who have progressed after receiving prior therapy or who have unresectable GBM.
Detailed Description: Despite recent advances, glioblastoma multiforme (GBM) remains an incurable malignancy with a short expected survival. c-MET signalling promotes invasive growth and has been described in various cancers. INC280 is a highly potent and selective c-MET inhibitor which also penetrates the blood-brain barrier. In this open-label, multicenter Phase 1b study, investigators determined the optimal dose of the INC280/bevacizumab combination to administer to patients. Enrollment has now expanded in order to treat 3 cohorts of GBM patients: those who progressed after ≥ first-line standard therapy, those who progressed after ≥ second-line therapy with INC280/bevacizumab, and those with unresectable GBM.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States
Yale School of Medicine, New Haven, Connecticut, United States
HCA Midwest - Kansas City, Kansas City, Missouri, United States
Oklahoma University Health Science Center, Oklahoma City, Oklahoma, United States
Tennessee Oncology PLLC, Nashville, Tennessee, United States
Name: Kent C. Shih, M.D.
Affiliation: SCRI Development Innovations, LLC
Role: STUDY_CHAIR