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

NCT04752813 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BPM31510IV-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 11

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 for subjects with newly diagnosed glioblastoma.

Conditions

Glioblastoma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• Efficacy will be assessed by subject progression free survival

  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.

  6 months and 12 months

Secondary Outcomes (2)

• Efficacy will be assessed by subject Overall survival

  5 years

• Safety and tolerability of BPM31510 and Vitamin K1 will be assessed by incidence of dose limiting toxicities (DLTs) and adverse events (AEs).

  30 days post treatment

Study Arms (1)

BPM31510, Vitamin K1, RT and TMZ

EXPERIMENTAL

Subjects will receive a BPM31510 96hr infusion once weekly for 8 wk. Prophylactic Vitamin K1 at a recommended dose of 10 mg will be given subcutaneously to all subjects prior to the beginning of each week of therapy. After 2 wk of treatment with BPM31510, subjects will start concurrent standard RT and TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for up to 12 cycles post BPM31510 treatment.

Drug: BPM31510; Other: Vitamin K1; Drug: Temozolomide (TMZ); Radiation: Radiation

Interventions

Radiation RADIATION

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

BPM31510, Vitamin K1, RT and TMZ

BPM31510 DRUG

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

BPM31510, Vitamin K1, RT and TMZ

Vitamin K1 OTHER

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

BPM31510, Vitamin K1, RT and TMZ

Temozolomide (TMZ) DRUG

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.

BPM31510, Vitamin K1, RT and TMZ

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BPGbio: lead

Study Sites (11)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University Cancer Center

Palo Alto, California, 94305, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Valley Health

Ridgewood, New Jersey, 07450, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

Texas Oncology

Austin, Texas, 78705, United States

Location

UT Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229, United States

Location

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Inova

Fairfax, Virginia, 22037, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Vitamin K 1; Temozolomide; Radiation

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Vitamin K; Naphthoquinones; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phytol; Diterpenes; Terpenes; Quinones; Polycyclic Compounds; Dacarbazine; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Physical Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: February 12, 2021
• Study Start: August 22, 2022
• Primary Completion (Estimated): August 25, 2026
• Study Completion (Estimated): August 26, 2030
• Last Updated: January 26, 2026

Record last verified: 2025-09

Locations

US (11)