Trial of AEO in New Glioblastoma (GBM)

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MetVital, Inc.
• Treatments: Temozolomide

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