Ireland
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Active, not recruiting Phase 2

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

NCT04752813 · tracked via the Priya Life Science USA tracker
Sponsor
BPGbio
Phase
Phase 2
Started
2022-08-22
Last updated
2026-01-26

Condition(s) studied

GlioblastomaGlioblastoma Multiforme

Investigational drug(s) / intervention(s)

BPM31510Vitamin K1Temozolomide (TMZ) →Radiation

BPM31510: Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.

Vitamin K1: Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg subcutaneously prior to the beginning of each week of BPM31510 therapy.

Temozolomide (TMZ): After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment.

Radiation: After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Efficacy will be assessed by subject progression free survival — 6 months and 12 months
    Progression free survival will be determined by measuring the proportion of subjects who have met RANO criteria for complete response, partial response , or stable disease at 6 mo and 12 mo following initiation of BPM31510.

Trial sites (11)

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

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04752813 on ClinicalTrials.gov ↗ ← All trials in the USA