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Trial of AEO in New Glioblastoma (GBM)

A Phase 2, Randomized, Open-Label Study of Anhydrous Enol-Oxaloacetate in Subjects With Newly Diagnosed Glioblastoma Multiforme

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04450160
Acronym
AEO
Enrollment
80
Registered
2020-06-29
Start date
2020-12-31
Completion date
2022-09-30
Last updated
2020-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma, Oxaloacetate, Seizures, Warburg

Brief summary

This is a multicenter, Phase 2, Proof-of-concept study in subjects with newly diagnosed glioblastoma multiforme (GBM). All subjects will receive standard of care therapy for the treatment of their GBM and any Anti-Epileptic Drug (AED) deemed necessary for their surgical resection of the GBM. Patients who are taking concomitant AEDs will be eligible for the study. Treatment with Anhydrous Enol-Oxaloacetate will be added to the Standard of Care. This study is testing adjuvant Anhydrous Enol-Oxaloacetate (AEO) in GBM, an orally active drug candidate which in animal studies has demonstrated decreased tumor growth rate and increased survival.

Detailed description

Currently, the multidisciplinary Standard of Care treatment for Glioblastoma multiforme includes maximal surgical resection of the tumor followed by radiotherapy plus concomitant and maintenance temozolomide chemotherapy.This study will treat newly diagnosed GBM patients by adding Anhydrous Enol-Oxaloacetate treatment to their current Standard of Care. In the body, Anhydrous Enol-Oxaloacetate (AEO) converts into Oxaloacetate, a metabolite important for many biochemical reactions in the body. On a cellular level, oxaloacetate treatment has been found to modify cancer metabolism in GBM cells, reversing the Warburg Effect, reducing glycolysis and reducing lactate production. In animals, oxaloacetate treatment has increased survival and reduced tumor growth of implanted GBM tumors. In other animal studies, oxaloacetate has also shown to have neuo-protective effects including positive effects on seizure development. .

Interventions

DRUGAnhydrous Enol-Oxaloacetate (AEO)

Oral supplementation with AEO along with the Standard of Care (Temozolomide)

OTHERStandard of Care

Standard of Care Temozolomide

Sponsors

MetVital, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* • Histopathologic diagnosis of glioblastoma multiforme * Standard of care maximal feasible surgical resection of the glioma * Post-operative pre-enrollment MRI-Note: measurable disease is not required * Concomitant anti-epileptic drugs * Hemoglobin \>9 g/dL * Platelets \>100,000/microliter (mcL) * \<3.0 Upper Limit of Normal Range (ULN) for Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) and/or Alkaline Phosphatase * \<2.0 Upper Limit of Normal Range (ULN) for serum creatinine * Karnofsky performance status \>70 * Mentally competent to follow study procedures * Male and female patients of childbearing potential must agree to use a dual method of contraception (a highly effective method of contraception in conjunction with barrier contraception) consistently and correctly from the first dose of study drug until 90 days after the last dose of study drug * Able to answer questions on the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire * Subject is willing and able to give informed consent and to follow instructions as per the protocol

Exclusion criteria

* • Concomitant treatment with carmustine wafers or tumor-treating electric fields (TTFields) * QT Interval corrected with the fridericia formula (QTcF) \>480ms * Significant concurrent illness / disease * Predicted life expectancy \< 6 months from date of randomization * Pregnancy * Enrollment in another clinical trial during the course of the study

Design outcomes

Primary

MeasureTime frameDescription
Overall Survival6 monthsMeasurement of Overall Survival
Progression Free Survival-66 monthsSurvival at 6 months

Secondary

MeasureTime frameDescription
Seizures6 monthsTime from randomization to first seizure
Chalfont-National Hospital Seizure Severity6 monthsMeasure of Seizure Severity Ranging from a minimum of 1 to a maximum of 27 with higher score indicating worse outcome
PROMIS-Cancer - Fatigue6 monthsMeasure of Fatigue Ranging from a minimum of 0 to a maximum of 95 with the higher score indicating worse outcome.

Contacts

Primary ContactAlan B Cash, MS
acash@MetVital.com858-947-5722

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026