ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-22

Study Completion:2030-08-26

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04752813

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Locations (Sites)

Cedars-Sinai Medical Center

Los Angeles, California, 90048

United States

Stanford University Cancer Center

Palo Alto, California, 94305

United States

Sansum Clinic

Santa Barbara, California, 93105

United States

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Valley Health

Ridgewood, New Jersey, 07450

United States

Mount Sinai Hospital

New York, New York, 10029

United States

Texas Oncology

Austin, Texas, 78705

United States

UT Health San Antonio Mays Cancer Center

San Antonio, Texas, 78229

United States

Virginia Cancer Specialists

Fairfax, Virginia, 22031

United States

Inova

Fairfax, Virginia, 22037

United States

Virginia Oncology Associates

Norfolk, Virginia, 23502

United States

Collaborators and Investigators

Sponsor: BPGbio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-22

Study Completion Date2030-08-26

Study Record Updates

Study Start Date2022-08-22

Study Completion Date2030-08-26

Terms related to this study

Additional Relevant MeSH Terms

Glioblastoma
Glioblastoma Multiforme