A Phase 2, Randomized, Open-Label Study of Anhydrous Enol-Oxaloacetate in Subjects With Newly Diagnosed Glioblastoma Multiforme
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 主要终点
- Overall Survival
研究概览
简要总结
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.
详细描述
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.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •• 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
研究组 & 干预措施
Standard of Care
Current GBM Treatment of surgery, radiation and chemotherapy with temozolomide.
干预措施: Standard of Care (Other)
AEO with Standard of Care
Anhydrous Enol-Oxaloacetate added to the Standard of Care (surgery, radiation and chemotherapy with temozolomide).
干预措施: Anhydrous Enol-Oxaloacetate (AEO) (Drug)
AEO with Standard of Care
Anhydrous Enol-Oxaloacetate added to the Standard of Care (surgery, radiation and chemotherapy with temozolomide).
干预措施: Standard of Care (Other)
结局指标
主要结局
Overall Survival
时间窗: 6 months
Measurement of Overall Survival
Progression Free Survival-6
时间窗: 6 months
Survival at 6 months
次要结局
- Seizures(6 months)
- Chalfont-National Hospital Seizure Severity(6 months)
- PROMIS-Cancer - Fatigue(6 months)