Trial of AEO in New Glioblastoma (GBM)

NCT04450160 | Unknown Phase 2 FDA Drug

• 1 other identifier: Terra-001-201
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Glioblastoma Multiforme

Keywords

Glioblastoma; Oxaloacetate; Seizures; Warburg

Outcome Measures

Primary Outcomes (2)

• Overall Survival

  Measurement of Overall Survival

  6 months

• Progression Free Survival-6

  Survival at 6 months

  6 months

Secondary Outcomes (3)

• Seizures

  6 months

• Chalfont-National Hospital Seizure Severity

  6 months

• PROMIS-Cancer - Fatigue

  6 months

Study Arms (2)

Standard of Care

PLACEBO COMPARATOR

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

Other: Standard of Care

AEO with Standard of Care

EXPERIMENTAL

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

Drug: Anhydrous Enol-Oxaloacetate (AEO); Other: Standard of Care

Interventions

Anhydrous Enol-Oxaloacetate (AEO) DRUG

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

AEO with Standard of Care

Standard of Care OTHER

Standard of Care Temozolomide

Also known as: Chemotherapy with Temozolomide

AEO with Standard of Care; Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetVital, Inc.: lead

Related Publications (3)

• Augur ZM, Doyle CM, Li M, Mukherjee P, Seyfried TN. Nontoxic Targeting of Energy Metabolism in Preclinical VM-M3 Experimental Glioblastoma. Front Nutr. 2018 Oct 5;5:91. doi: 10.3389/fnut.2018.00091. eCollection 2018.

  PMID: 30349820 BACKGROUND

• Ruban A, Berkutzki T, Cooper I, Mohar B, Teichberg VI. Blood glutamate scavengers prolong the survival of rats and mice with brain-implanted gliomas. Invest New Drugs. 2012 Dec;30(6):2226-35. doi: 10.1007/s10637-012-9799-5.

  PMID: 22392507 BACKGROUND

• Yamamoto HA, Mohanan PV. Effect of alpha-ketoglutarate and oxaloacetate on brain mitochondrial DNA damage and seizures induced by kainic acid in mice. Toxicol Lett. 2003 Jul 20;143(2):115-22. doi: 10.1016/s0378-4274(03)00114-0.

  PMID: 12749815 BACKGROUND

MeSH Terms

Conditions

Glioblastoma; Seizures

Interventions

Standard of Care; Drug Therapy; Temozolomide

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Therapeutics; Dacarbazine; Triazenes; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Alan B Cash, MS

CONTACT

858-947-5722; acash@MetVital.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 29, 2020
• Study Start: December 1, 2020
• Primary Completion: July 1, 2022
• Study Completion: September 1, 2022
• Last Updated: June 29, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share