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

Running, not enrolling · Phase 2

Conditions studied: Glioblastoma, Glioblastoma Multiforme

In brief

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.

Key facts

Study ID

NCT04752813

Run by

BPGbio

People needed

50

Starts

2022-08-22

Expected to finish

2030-08-26

Last updated by the study team

2026-01-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Patients who are not eligible for definitive surgical resection.
• Patients on decadron daily dosing more than 2 mg.
• 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).
• Uncontrolled concurrent illness.
• 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.
• 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 allergy to CoQ10.
• Known allergy or adverse reaction to Vitamin K1.
• Pregnant or lactating.
• 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.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Stanford University Cancer Center — Palo Alto, California, United States
• Sansum Clinic — Santa Barbara, California, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Valley Health — Ridgewood, New Jersey, United States
• Mount Sinai Hospital — New York, New York, United States
• Texas Oncology — Austin, Texas, United States
• UT Health San Antonio Mays Cancer Center — San Antonio, Texas, United States
• Virginia Cancer Specialists — Fairfax, Virginia, United States
• Inova — Fairfax, Virginia, United States
• Virginia Oncology Associates — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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