Clinical Drug Experience Knowledgebase

Criteria

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