Combining BPM31510 and Vitamin K1 with standard treatment for newly diagnosed glioblastoma

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

This study is testing if adding a new treatment called BPM31510 and Vitamin K1 to standard radiation and chemotherapy can help people with newly diagnosed glioblastoma feel better and live longer.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BPGbio (industry)
• Drugs / interventions: chemotherapy, immunotherapy, radiation
• Locations: 13 sites (Los Angeles, California and 12 other locations)
• Trial ID: NCT04752813 on ClinicalTrials.gov

What this trial studies

This Phase 2 therapeutic study evaluates the safety and efficacy of BPM31510 when added to the conventional treatment of radiation therapy (RT) and temozolomide (TMZ) in patients with newly diagnosed glioblastoma. The study begins with a dose-confirmation phase to determine the appropriate dosage of BPM31510, starting at 110 mg/kg/week, with monitoring for dose-limiting toxicities (DLTs) over a 30-day period post-RT. Participants will be closely monitored for any adverse effects and will continue to receive follow-up assessments for up to five years to evaluate long-term safety and efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with newly diagnosed, pathologically verified glioblastoma who have not received prior treatments.

Not a fit: Patients with a history of significant tumor-related cerebral hemorrhage or those with uncontrolled coagulopathies may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with glioblastoma by enhancing the effectiveness of standard therapies.

How similar studies have performed: While this specific combination has not been extensively tested, similar approaches in glioblastoma treatment have shown promise in enhancing therapeutic efficacy.

Eligibility 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.

Where this trial is running

Los Angeles, California and 12 other locations

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

Study contacts

• Study coordinator: Vijay Modur, MD, PhD

Conditions: Glioblastoma, Glioblastoma Multiforme