Spots Global Cancer Trial Database for A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
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Trial Identification
Brief Title: A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma
Official Title: A Phase 1/2 Study of Selinexor in Combination With Standard of Care (SoC) Therapy for Newly Diagnosed or Recurrent Glioblastoma
Study ID: NCT04421378
Conditions
Study Description
Brief Summary: This is a Phase 1/2 study of selinexor in combination with standard of care (SoC) therapy for newly diagnosed glioblastoma (nGBM) or recurrent glioblastoma (rGBM). This study will be conducted in 2 phases: a Phase 1a dose finding study followed by Phase 1b (dose expansion) and a Phase 2 randomized efficacy exploration study and will independently evaluate 3 different combination regimens in 3 treatment arms in patients with nGBM (Arms A and B) or with rGBM (Arm C). * Arm A: evaluating the combination of selinexor with radiation therapy (S-RT) in nGBM participants with uMGMT * Arm B: evaluating the combination of selinexor with radiation therapy and temozolomide (TMZ) (S-TRT) in nGBM participants with methylated-O6-methylguanine-DNA-methyltransferase (mMGMT) * Arm C: evaluating the combination of selinexor with lomustine (or carmustine, if lomustine is not available) (S-L/C) in rGBM participants regardless of MGMT status * Arm D: evaluating the combination of selinexor with bevacizumab in rGBM participants regardless of MGMT status * Arm E: evaluating the combination of selinexor with tumor treating fields (TTField) in rGBM participants regardless of MGMT status
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama, Birmingham, Alabama, United States
University of Southern California (USC Norris Comprehensive Cancer Center and LAC+USC Medical Center), Los Angeles, California, United States
University of California, San Francisco, California, United States
Baptist Hospital of Miami Cancer Institute, 8900 North Kendall Drive, Miami, Florida, United States
Piedmont Healthcare, Atlanta, Georgia, United States
Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Dana Farber Cancer Institute, Boston, Massachusetts, United States
Hackensack Meridian Health, 92 Second Street, Hackensack, New Jersey, United States
Atlantic Health Systems Hospital Corp., Morristown, New Jersey, United States
Northwell Health, Lake Success, New York, United States
Columbia University Irving Medical Center, New York, New York, United States
Lenox Hill Hospital-Northwell Health, New York, New York, United States
Cleveland Clinic, Cleveland, Ohio, United States
MD Anderson Cancer Center, Houston, Texas, United States
University of Utah - Huntsman Cancer Institute, Salt Lake City, Utah, United States
University of Washington - Alvord Brain Tumor Center, Seattle, Washington, United States
Princess Margaret Hospital (PMH), Toronto, Ontario, Canada
Contact Details
Name: Andrew B Lassman, MD
Affiliation: Columbia University
Role: PRINCIPAL_INVESTIGATOR
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