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

Trial ID: NCT04752813

Interventional - Phase 2 - Active, not recruiting

This is a single-arm, non-randomized, open-label Phase 2 therapeutic study that will assess the effects of adding BPM31510 onto a conventional treatment framework of RT and concurrent TMZ chemotherapy for subjects with newly diagnosed glioblastoma.

Conditions

• Glioblastoma
• Glioblastoma Multiforme

Interventions

• BPM31510
• Vitamin K1
• Temozolomide (TMZ)
• Radiation

Eligibility

Inclusion criteria

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

Exclusion criteria

• 1. History of clinically significant tumor-related cerebral hemorrhage.
• 2. Patients with multicentric disease defined by tumors which have multiple discrete areas of contrast-enhancing tumor without connecting T2/FLAIR signal abnormality.
• 3. Patients with diffuse leptomeningeal disease.
• 4. Patients who are not eligible for definitive surgical resection.
• 5. Patients on decadron daily dosing more than 2 mg.
• 6. Any serious cardiac history as per protocol.
• 7. Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.
• 8. Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).
• 9. Uncontrolled concurrent illness.
• 10. 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.
• 11. Receiving any of the following medications:
• 1. Therapeutic doses of any anticoagulant, including low-molecular weight heparin. Concomitant use of warfarin, even at prophylactic doses, is prohibited.
• 2. Digoxin, digitoxin, lanatoside C, or any type of digitalis alkaloids.
• 3. Antiangiogenic drugs (ie, Avastin) either in the past 2 wk or if anticipated within the next 2 wk of informed consent.
• 4. Theophylline
• 12. Known allergy to CoQ10.
• 13. Known allergy or adverse reaction to Vitamin K1.
• 14. Pregnant or lactating.
• 15. 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.
• 16. Patients with a contraindication to radiation.

Sponsor

BPGbio

Source: ClinicalTrials.gov

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