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

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.

Conditions

Glioblastoma, Glioblastoma Multiforme

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Glioblastoma
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Palo Alto

Stanford University Cancer Center, Palo Alto, California, United States, 94305

Santa Monica

Sarcoma Oncology Research Center, Santa Monica, California, United States, 90403

Ridgewood

Valley Health, Ridgewood, New Jersey, United States, 07450

New York

Mount Sinai Hospital, New York, New York, United States, 10029

Austin

Texas Oncology, Austin, Texas, United States, 78705

Fairfax

Virginia Cancer Specialists, Fairfax, Virginia, United States, 22031

Fairfax

Inova, Fairfax, Virginia, United States, 22037

Seattle

University of Washington, Seattle, Washington, United States, 98101

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

BPGbio,

Study Record Dates

2025-12-30