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Trial of AEO in New Glioblastoma (GBM)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04450160
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

MetVital, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma Multiforme
Study Website: View Trial Website
Additional Details

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. .

Arms & Interventions

Arms

Placebo Comparator: Standard of Care

Current GBM Treatment of surgery, radiation and chemotherapy with temozolomide.

Experimental: AEO with Standard of Care

Anhydrous Enol-Oxaloacetate added to the Standard of Care (surgery, radiation and chemotherapy with temozolomide).

Interventions

Drug: - Anhydrous Enol-Oxaloacetate (AEO)

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

Other: - Standard of Care

Standard of Care Temozolomide

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Alan B Cash, MS

acash@MetVital.com

858-947-5722

For additional contact information, you can also visit the trial on clinicaltrials.gov.