A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)

Prior treatment

• Patients who are not eligible for definitive surgical resection.
• Uncontrolled concurrent illness.
• Receiving any of the following medications:
  • Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
  • Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
  • Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent.
  • Theophylline
• Known to be positive for the human immunodeficiency virus (HIV). Note: HIV testing is not required for eligibility, but if performed previously and was positive, the subject is ineligible.
• Patients with a contraindication to radiation.

Other illness

• History of clinically significant tumor-related cerebral hemorrhage.
• Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
• Patients with diffuse leptomeningeal disease.
• Any serious cardiac history as per protocol.
• Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.
• Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
• Prior malignancy except for non-melanoma skin cancer and carcinoma in situ (of the cervix or bladder), unless diagnosed and definitively treated more than 3 y prior to first dose of study drug.
• Known allergy to CoQ10.
• Known allergy or adverse reaction to Vitamin K1.

Other

• Patients on decadron daily dosing more than 2 mg.
• Pregnant or lactating.

• Subjects with newly diagnosed pathologically verified GB.
• No prior RT, chemotherapy, immunotherapy, or targeted agents administered specifically for the lesion being treated.
• Age ≥18 y.
• Life expectancy ≥3 months.
• Karnofsky performance score ≥60.
• Adequate organ and marrow function as per protocol.
• Ability for subject to understand and the willingness to sign a written ICF.
• Subjects of childbearing potential must agree to use hormonal or barrier birth control with spermicidal gel to avoid pregnancy during the study.
• Be at least 15 d out and not more than 50 d from surgery.