CoQ10 Supplement for Glioblastoma

Overseen By Priya Yerraballa

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Stanford University

Must not be taking: Insulin

Disqualifiers: Refuse IV, Allergy MRI contrasts, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Varies

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called BPM31510, a special form of CoQ10 (a dietary supplement), to determine if it can improve outcomes for people with glioblastoma, a type of brain cancer. Researchers aim to assess whether this treatment, combined with standard care, is more effective by using Deuterium Metabolic Imaging (DMI) to monitor brain changes. Candidates for this trial include those who have agreed to participate in a related study and do not have certain medical conditions, such as diabetes requiring insulin. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in glioblastoma treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but if you are diabetic and taking insulin, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BPM31510, a special form of CoQ10, has been tested in several studies without major safety issues. These studies found the treatment generally safe, even for conditions like high-grade glioma, a type of brain tumor. A safety committee approved a dose of 110 mg/kg for further research, indicating it was well-tolerated at this level. While the treatment remains under study, current evidence suggests it is safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for glioblastoma, which typically involve surgery, radiation, and chemotherapy, the investigational treatment BPM31510 offers a unique approach. Researchers are excited because BPM31510 is centered around CoQ10, a compound that may help alter the metabolism of cancer cells. By potentially affecting how glioblastoma cells process energy, this treatment could provide a new way to target the tumor without the harsh side effects associated with conventional therapies. This novel mechanism of action is what makes BPM31510 a promising candidate in the fight against this aggressive brain cancer.

What evidence suggests that BPM31510 could be an effective treatment for Glioblastoma?

Research has shown that BPM31510, a type of CoQ10, may help treat glioblastoma, a kind of brain cancer. Studies have found that combining BPM31510 with standard treatments like the chemotherapy drug TMZ and radiotherapy can enhance their effectiveness. Specifically, patients experienced longer periods where their cancer did not progress. Another study found that BPM31510 targets aggressive cancer cells while mostly sparing healthy cells. This suggests that BPM31510 could be a valuable addition to current glioblastoma treatments. Participants in this trial will receive a different treatment, Deuterated Glucose, combined with MRI imaging to study its effects. ^{1 5 6 7 8}

Who Is on the Research Team?

Lawarence Recht

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for individuals with Glioblastoma who can consent to the study and are part of a Phase II trial for BPM31510. Women able to have children must test negative for pregnancy. It's not suitable for insulin-dependent diabetics, those who refuse IVs, or people allergic to MRI contrast agents.

Inclusion Criteria

Ability to understand and the willingness to provide written informed consent.

Any participant that consents to entry into the Phase II BPM31510 parent study (BPM31510IV-11)

I am capable of becoming pregnant and have a negative pregnancy test.

Exclusion Criteria

I am diabetic and take insulin.

I refuse to receive treatments through an IV.

Allergy to MRI contrasts

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BPM31510, a lipid nano dispersion of CoQ10, along with standard treatment for Glioblastoma. They will also undergo metabolic imaging with deuterated glucose and MRI.

Varies

1 visit for MRI and DMI study

Follow-up

Participants are monitored for overall survival and progression-free survival.

up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• BPM31510

Trial Overview The study aims to assess how well DMI (using [6,6-²H₂]-Glucose) predicts treatment success when adding BPM31510 (a CoQ10 lipid nano dispersion) to standard GBM therapy.

How Is the Trial Designed?

Group I: Deuterated Glucose + MRI Experimental Treatment 1 Intervention

Participants will receive \[6,6-²H₂\]-glucose orally at a dose of 0.75g per kg of body weight (maximum 60g), dissolved in 200-500mL of water. Approximately 45 minutes after ingestion, participants will undergo an MRI scan consisting of a 30-minute conventional MRI brain study followed by a 1-hour Deuterium Metabolic Imaging (DMI) study. A Gadolinium contrast agent may be administered if more than 4 weeks have passed since the last enhanced MRI scan.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Coenzyme Q10 (CoQ10) significantly reduced tumor volume in glioblastoma multiforme (GBM) models by decreasing hypoxia and vascularization, while also limiting inflammatory cell infiltration.

CoQ10's effects on GBM were linked to the downregulation of key proteins like HIF-1α and NF-kB, leading to changes in tumor cell behavior, including reduced migration and invasion, suggesting it could be a valuable addition to current GBM therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CoQ10 reduces glioblastoma growth and infiltration through proteome remodeling and inhibition of angiogenesis and inflammation. Frontiñán-Rubio, J., Llanos-González, E., García-Carpintero, S., et al.[2023]

Coenzyme Q10 (CoQ10) enhances the effectiveness of temozolomide (TMZ) in treating chemoresistant glioblastoma cells by increasing sensitivity and reducing cell proliferation, as demonstrated in a study using a TMZ-resistant rat glioma cell line.

CoQ10 not only improves the cytotoxic effects of TMZ but also suppresses glioma cell invasion by inhibiting key proteins involved in cell migration, suggesting it could be a valuable addition to standard glioblastoma therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modulation of Antioxidant Potential with Coenzyme Q10 Suppressed Invasion of Temozolomide-Resistant Rat Glioma In Vitro and In Vivo. Burić, SS., Podolski-Renić, A., Dinić, J., et al.[2020]

Coenzyme Q10 enhances the growth and viability of glioma cells in serum-free conditions by restoring mitochondrial function and increasing energized mitochondria.

The mechanism behind this effect involves a decrease in intracellular reduced glutathione, which activates key signaling pathways including proteinkinase C, ERK1/2, and phosphoinositol-3-kinase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GLIOMA CELL PROLIFERATION MEDIATED BY COENZYME Q10 AT SERUM DEPRIVATION IN VITRO. Krylova, NG., Kulahova, TA., Koren, SV., et al.[2018]

Endogenous coenzyme Q10 (CoQ10) levels were found to be higher in non-tumor brain tissues compared to all grades of astrocytoma, indicating a potential deficiency in CoQ10 as the tumor malignancy increases.

Several COQ proteins essential for CoQ10 biosynthesis were significantly lower in Grade IV astrocytoma tissues, suggesting that mitochondrial dysfunction and impaired CoQ10 maintenance may contribute to the progression of this type of brain cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Levels of Coenzyme Q10 and Several COQ Proteins in Human Astrocytoma Tissues Are Inversely Correlated with Malignancy. Yen, HC., Chen, BS., Yang, SL., et al.[2022]

Ubidecarenone, delivered through BPM31510, shows a significant therapeutic potential against glioblastoma, as it selectively targets cancer cells with elevated oxidative stress, leading to increased sensitivity compared to non-cancer cells.

In vivo studies demonstrated that treatment with ubidecarenone resulted in over 25% long-term survival in a rodent glioma model, indicating its effectiveness in enhancing survival in aggressive cancer types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High levels of ubidecarenone (oxidized CoQ10) delivered using a drug-lipid conjugate nanodispersion (BPM31510) differentially affect redox status and growth in malignant glioma versus non-tumor cells. Sun, J., Patel, CB., Jang, T., et al.[2021]

A systematic review of six studies, including three randomized trials, suggests that oral supplementation with coenzyme Q10 (CoQ10) may help protect against cardiotoxicity or liver toxicity in cancer patients undergoing treatment, particularly those receiving anthracyclines.

However, the evidence is not conclusive due to inadequate reporting and questionable validity of outcome measures, indicating a need for more rigorous trials to confirm the efficacy of CoQ10 in improving the tolerability of cancer treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of coenzyme Q10 for improved tolerability of cancer treatments: a systematic review. Roffe, L., Schmidt, K., Ernst, E.[2022]

Citations

1. biospace.com biospace.com/press-releases/bpgbio-presents-phase-2-glioblastoma-data-on-bpm31510-at-esmo-2025

BPGbio Presents Phase 2 Glioblastoma Data on ... Endpoints: Primary endpoints are progression-free survival at 6 months (PFS6) and 12 months (PFS12); secondary endpoints include overall ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04752813

NCT04752813 | A Study of BPM31510 With Vitamin K1 in ... 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 ...

3. annalsofoncology.org annalsofoncology.org/article/S0923-7534(25)02216-1/fulltext

722eTiP Interim analysis of a phase II study of BPM31510 ... The phase 2 trial in newly diagnosed patients with glioblastoma test ... BPM31510 results in improved efficacy of TMZ and radiotherapy. Trial design.

4. globenewswire.com globenewswire.com/news-release/2025/10/16/3167784/0/en/BPGbio-Presents-Phase-2-Glioblastoma-Data-on-BPM31510-at-ESMO-2025.html

BPGbio Presents Phase 2 Glioblastoma Data on ... Endpoints: Primary endpoints are progression-free survival at 6 months (PFS6) and 12 months (PFS12); secondary endpoints include overall ...

5. nature.com nature.com/articles/s41598-020-70969-0

High levels of ubidecarenone (oxidized CoQ 10 ) delivered ... These findings suggest a selective therapeutic potential for BPM31510 in the highly aggressive glioma cancer cells with minimal impact on non- ...

6. annalsofoncology.org annalsofoncology.org/article/S0923-7534(24)02087-8/fulltext

499TiP A phase II study of BPM31510 (a lipid ... The Data and Safety Monitoring Committee approved the 110 mg/kg dose level and trial continuation. The BPM31510IV-11 trial will enroll approximately 50 patients ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03020602

BPM31510 in Treating Patients With Recurrent High-Grade ... Primary Objective: Assess the safety and tolerability of BPM31510 plus vitamin K in subjects with high-grade glioma(HGG), defined as anaplastic astrocytoma (AA) ...

8. withpower.com withpower.com/trial/phase-2-glioblastoma-2025-9b745

CoQ10 Supplement for Glioblastoma It has been used in various studies, including those involving glioblastoma, with no major safety concerns reported.