Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT04450160
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04450160
Study Brief:
Protocol Section:
NCT04450160