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

Trial ID or NCT#

NCT04752813

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 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. 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:
  2. 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. Theophylline12. 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.
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Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD
Neuro-oncologist
Clinical Professor, Adult Neurology Clinical Professor (By courtesy), Neurosurgery

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Contact

Hari Priya Yerraballa
650-724-9363

View on ClinicalTrials.gov