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


I'm Interested

Trial ID: NCT04752813


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)

Stanford Investigator(s)

Seema Nagpal, MD
Seema Nagpal, MD

Clinical Professor, Neurology & Neurological Sciences Clinical Professor (By courtesy), Neurosurgery


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

   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.


drug: BPM31510

other: Vitamin K1

drug: Temozolomide (TMZ)

radiation: Radiation


I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Hari Priya Yerraballa
1 650-724-9363

New Trial Alerts

Receive email alerts when trials open to patients.