A Study of the Safety and Pharmacokinetics of BRCX014 in Patients With Glioblastoma

Inclusion Criteria: * Histopathologically confirmed glioblastoma (astrocytoma WHO grade IV) * MGMT promoter methylation status is negative * Brain MRI confirmation of disease according to RANO (Response Assessment in Neuro-Oncology) criteria * Completion of standard-of-care temozolomide-based chemoradiation for post-operative treatment of glioblastoma plus two-to-six week "washout" period and stable-to-improved baseline brain MRI. * Male and female subjects between the ages of 18 and 85 years * Karnofsky Performance Score ≥ 60% * Expected survival of at least six months from the day of enrollment * No severe dysfunction of major organs (e.g., bone marrow, liver, kidneys, heart, lungs, etc.) and laboratory results from up to 14 days prior to enrollment fall within criteria: * Hemoglobin \> 10 g/dL * Leukocytes ≥ 3,000 per μl * Absolute neutrophil count ≥ 1,500 per μl * Platelet count \> 100,000 per μl * BUN \< 25 mg * Serum creatinine within normal institutional limits OR Creatinine clearance ≥ 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal * Total serum bilirubin within normal institutional limits * ALT (SGPT) ≤ 2.5× the institutional upper limit of normal OR AST (SGOT) ≤ 2.5× the institutional upper limit of normal * Ability to take medication sublingually * Willingness and ability to comply with scheduled visits, laboratory tests, and other trial procedures * Accessible for treatment and follow-up * Female subjects: Use of two approved forms of contraceptives * Male subjects: Use of two approved forms of contraceptives and willing to instruct their partners to use one form of contraceptive as well * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * MGMT promoter methylation status is positive (i.e., promoter is methylated) * Prior radiotherapy for GBM within two (2) weeks of entering the study or has not recovered from adverse events due to agents administered more than four (4) weeks earlier * Prior chemotherapy, immunotherapy, or radiation therapy for other cancers (except for treatment of limited curable skin cancers) * Currently or recently (in the previous six months) part of a clinical trial involving any other investigational agents * Hypersensitivity or allergy to any ingredient in the study drug * Receiving any medications or substances that are known substantial inhibitors or inducers of CYP3A4 * Consumption of grapefruit or grapefruit juice three (3) days prior to screening or unwillingness to abstain from consuming grapefruit in any form during the study * Uncontrolled intercurrent illness that would limit compliance with study requirements * Pregnancy, possible pregnancy, plans for pregnancy, or active lactation or nursing * Positive HIV or hepatitis status * Unwillingness or inability to take medication sublingually * Diagnosis of cancer more than 120 days prior to initial visit * History of prior malignancy except curatively treated skin cancers * History of prior chemotherapy or radiation for other cancers (except for treatment of limited curable skin cancers) before initial visit * Clinically significant unstable medical conditions other than GBM * Clinically relevant symptoms or clinically significant illness in the four (4) weeks prior to screening or registration, other than GBM * Clinically significant unstable medical conditions, other than GBM, deemed by the investigator to pose an unacceptable risk to the patient * History of substance abuse within the last two years * Current use of recreational or medicinal cannabis, synthetic cannabinoid-based medications, or alcohol, or planned use while in the study * Evidence of any diseases or conditions that may interfere with the study or interpretation of study results * Inability or unwillingness to cooperate with the study procedures * Known history of severe depression or psychiatric disorders, or active suicidal ideation * Subjects with close affiliation with an investigational site * Absence of or unwillingness to sign and date the informed consent document