Status:
ACTIVE_NOT_RECRUITING
A Study of BPM31510 With Vitamin K1 in Subjects With Newly Diagnosed Glioblastoma (GB)
Lead Sponsor:
BPGbio
Conditions:
Glioblastoma
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
Detailed Description
The study will start with a dose-confirmation phase to establish safety of BPM31510 in combination with RT and TMZ. This phase will follow a standard 3+3 dose design with the starting dose of BPM31510...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 26 2030
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04752813
Start Date
August 22 2022
End Date
August 26 2030
Last Update
September 9 2025
Active Locations (11)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Stanford University Cancer Center
Palo Alto, California, United States, 94305
3
Sansum Clinic
Santa Barbara, California, United States, 93105
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215