Study of Niacin in Glioblastoma

Inclusion Criteria:

• Adults, 18 years old to 75 years old inclusive.
• New diagnoses of glioblastoma IDH wild type.
• ECOG 0-2 (Appendix I).
• Candidates for concurrent standard first line treatment according to theirNeuro-Oncologist and Radiotherapy Oncologist after maximal safe debulkingneurosurgery. Patients that only had biopsy are included as long as pathology confirmsthe diagnoses and it is considered the maximal safe procedure for that patient.
• Adequate hematological, renal and hepatic function (see details in Section 4.1 of theprotocol).
• Absence of known human immunodeficiency virus (HIV) infection, chronic hepatitis B orhepatitis C infection.
• Absence of any other serious medical condition according to the medical judgment ofthe Qualified Investigator prior to registration.
• Absence of any medical condition, which could interfere with oral medication intake.
• Signed informed consent.
• Patients must be accessible for treatment and follow-up. Patients registered on thistrial must be treated and followed at the participating centre.
• Women/men of childbearing potential must have agreed to use a highly effectivecontraceptive method.

Exclusion Criteria:

• Glioblastoma, IDH-mutant.
• Patients with a history of other malignancies, except: adequately treated non-melanomaskin cancer, curatively treated in-situ cancer of the cervix, or other solid tumourscuratively treated with no evidence of disease for ≥ 5 years. Additionally, any lowgrade or low risk malignancy not requiring treatment will not exclude a patient fromparticipation in the trial.
• Known hypersensitivity to niacin.
• Inability to provide informed consent.
• Active liver disease or unexplained persistent elevations of serum transaminases.
• Active peptic ulcer or active gastrointestinal bleeding.
• Unstable angina or myocardial infarction within 6 months.
• Symptomatic gout.
• Patients on 3-hydroxy-3-methylglutaryl-coenzyme (HMG-COA reductase) inhibitors thatcannot discontinue them at least 2 weeks before starting Niacin CRT™.
• Any prior systemic treatment for glioblastoma (standard, evidence based orexperimental) or radiotherapy/radiosurgery.
• Individuals with MRI non-compatible metal in the body, or unable to undergo MRIprocedures including allergy to gadolinium.
• Patients unfit for any treatment component, including contraindications forradiotherapy or Connective Tissue Disease.
• Is currently participating and receiving study therapy or has participated in a studyof an investigational agent and received study therapy or used an investigationaldevice within 4 weeks of the first dose of treatment.
• Has known psychiatric or substance abuse disorders that would interfere withcompliance with the requirements of the trial.
• Pregnant, breast-feeding, unable and/or unwilling to use contraception methods.