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

Launched by BPGBIO · Feb 11, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a new treatment called BPM31510 when added to standard therapies for patients with newly diagnosed glioblastoma, a type of brain cancer. The trial aims to see if this combination can improve the effectiveness of the usual treatments, which include radiation therapy and a chemotherapy medication called temozolomide (TMZ). It is important to note that this is a Phase 2 study, meaning it is focused on evaluating the treatment's safety and effectiveness in patients who have just been diagnosed.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of glioblastoma without having received any previous treatments like radiation or chemotherapy for their cancer. They should be at least two weeks post-surgery and have a good overall health score. Participants can expect to receive the new treatment alongside their regular cancer care and will be monitored for any side effects or benefits. This trial is currently recruiting participants, so if you or a loved one meets the eligibility criteria, there may be an opportunity to take part in this promising study.

Gender

ALL

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.