A Study of Selinexor in Combination With Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

  • STATUS
    Recruiting
  • participants needed
    474
  • sponsor
    Karyopharm Therapeutics Inc
Updated on 8 February 2023
platelet count
cancer
corticosteroids
measurable disease
MRI
neutrophil count
blood transfusion
bevacizumab
carmustine
recurrent disease
temozolomide
brain tumor
recurrent glioblastoma
lomustine
renal function test
methylated
ccnu

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

Details
Condition Glioblastoma Multiforme
Treatment bevacizumab, carmustine, Selinexor, Temozolomide (TMZ), Lomustine (CCNU), Standard Fractionated Radiation therapy (RT), TTField
Clinical Study IdentifierNCT04421378
SponsorKaryopharm Therapeutics Inc
Last Modified on8 February 2023

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