Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    04450160
Previous Study | Return to List | Next Study

Trial of AEO in New Glioblastoma (GBM) (AEO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04450160
Recruitment Status : Not yet recruiting
First Posted : June 29, 2020
Last Update Posted : June 29, 2020
Sponsor:
Information provided by (Responsible Party):
MetVital, Inc.

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.


Condition or disease Intervention/treatment Phase
Glioblastoma Multiforme Drug: Anhydrous Enol-Oxaloacetate (AEO) Other: Standard of Care Phase 2

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.

.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Open-Label Study of Anhydrous Enol-Oxaloacetate in Subjects With Newly Diagnosed Glioblastoma Multiforme
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Standard of Care
Current GBM Treatment of surgery, radiation and chemotherapy with temozolomide.
Other: Standard of Care
Standard of Care Temozolomide
Other Name: Chemotherapy with Temozolomide

Experimental: AEO with Standard of Care
Anhydrous Enol-Oxaloacetate added to the Standard of Care (surgery, radiation and chemotherapy with temozolomide).
Drug: Anhydrous Enol-Oxaloacetate (AEO)
Oral supplementation with AEO along with the Standard of Care (Temozolomide)

Other: Standard of Care
Standard of Care Temozolomide
Other Name: Chemotherapy with Temozolomide




Primary Outcome Measures :
  1. Overall Survival [ Time Frame: 6 months ]
    Measurement of Overall Survival

  2. Progression Free Survival-6 [ Time Frame: 6 months ]
    Survival at 6 months


Secondary Outcome Measures :
  1. Seizures [ Time Frame: 6 months ]
    Time from randomization to first seizure

  2. Chalfont-National Hospital Seizure Severity [ Time Frame: 6 months ]
    Measure of Seizure Severity Ranging from a minimum of 1 to a maximum of 27 with higher score indicating worse outcome

  3. PROMIS-Cancer - Fatigue [ Time Frame: 6 months ]
    Measure of Fatigue Ranging from a minimum of 0 to a maximum of 95 with the higher score indicating worse outcome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04450160


Contacts
Layout table for location contacts
Contact: Alan B Cash, MS 858-947-5722 acash@MetVital.com

Sponsors and Collaborators
MetVital, Inc.
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: MetVital, Inc.
ClinicalTrials.gov Identifier: NCT04450160    
Other Study ID Numbers: Terra-001-201
First Posted: June 29, 2020    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MetVital, Inc.:
Glioblastoma
Oxaloacetate
Seizures
Warburg
Additional relevant MeSH terms:
Layout table for MeSH terms
Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Temozolomide
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents