Status:
UNKNOWN
Trial of AEO in New Glioblastoma (GBM)
Lead Sponsor:
MetVital, Inc.
Conditions:
Glioblastoma Multiforme
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 GB...
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 temoz...
Eligibility Criteria
Inclusion
- • 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
- • 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
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04450160
Start Date
December 1 2020
End Date
September 1 2022
Last Update
June 29 2020
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