Clinical trial · Interventional

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

NCT04450160CI-TRIAL-00045712AEOunknownPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Glioblastoma Multiforme	Glioblastoma	CURATED_BROADER	0.80

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Anhydrous Enol-Oxaloacetate (AEO)	Drug	—	UNRESOLVED
Standard of Care	Other	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
PLACEBO_COMPARATOR
label
Standard of Care
description
Current GBM Treatment of surgery, radiation and chemotherapy with temozolomide.
interventionNames
1. Other: Standard of Care
type
EXPERIMENTAL
label
AEO with Standard of Care
description
Anhydrous Enol-Oxaloacetate added to the Standard of Care (surgery, radiation and chemotherapy with temozolomide).
interventionNames
1. Drug: Anhydrous Enol-Oxaloacetate (AEO)
2. Other: Standard of Care

Primary outcomes (2)

measure
Overall Survival
timeFrame

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (3)

BACKGROUNDAugur 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
BACKGROUNDRuban 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
BACKGROUNDYamamoto 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