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

• Status: Recruiting
• Trial end date: 2027-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Berg, LLC
• Treatments: Temozolomide; Vitamin K; Vitamin K 1

Criteria

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 14 d out from surgery.

Exclusion Criteria:

1. No evidence of residual tumor.

2. History of clinically significant tumor-related cerebral hemorrhage.

3. Any serious cardiac history as per protocol.

4. Uncontrolled or severe coagulopathies or a history of clinically significant bleeding within the past 6 months.

5. Known predisposition for bleeding such as von Willebrand's disease or other such condition(s).

6. Uncontrolled concurrent illness.

7. 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.

8. 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

9. Known allergy to CoQ10.

10. Known allergy or adverse reaction to oral, subcutaneous, or IV Vitamin K1.

11. Pregnant or lactating.

12. 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.