Early Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You must be willing and able to give your agreement to participate before any study activities begin.
• You must be an adult (18 or older) who has been diagnosed with a specific type of brain tumour called IDH-wild type glioblastoma, and your tumour has come back for the first or second time after being treated with radiation therapy and the chemotherapy drug temozolomide.
• Your returned tumour must be in a location where surgery to remove it is possible.
• You must be well enough to carry out most daily activities (a doctor will assess this using a standard scale).
• If you are a woman who could become pregnant, you must have a negative pregnancy test at the start of the study.
• If you could become pregnant or father a child, you must agree to use two highly effective methods of contraception from the start of the study until 180 days after your last dose of the study drug.
• You must be able to have brain MRI scans.
• If you are a woman, you must not be breastfeeding during the study and for 180 days after your last dose of the study drug.
• If you are a man, you must agree not to donate sperm during the study and for at least 6 months after stopping the study drug.
• You must be receiving your standard-of-care brain surgery in Alberta, Canada.

Who may not be able to join:

• You have a history of a significantly weakened heart (specifically, a lower-than-normal pumping function called low ejection fraction).
• You are pregnant, breastfeeding, or are unwilling or unable to follow the contraception requirements of the study.
• You are not able to give your own informed consent to participate.
• Your blood test results are outside acceptable ranges — for example, low red blood cells, low white blood cells, low platelets, or poor liver or kidney function (confirm with trial site for specific values).
• You have a significant bowel condition where diarrhoea is a major problem, such as Crohn's disease or a condition affecting how your gut absorbs food.
• You have a history of a lung condition called interstitial lung disease (scarring or inflammation of the lungs).
• You have severe liver disease (confirm with trial site).
• You have a significantly abnormal heart rhythm reading on an ECG test.
• You have a rare inherited condition affecting how your body handles certain sugars (such as galactose intolerance or a related condition) (confirm with trial site).
• You already have a known build-up of fluid around your lungs.
• You have an active hepatitis B or C infection, or a known history of HIV.
• You have a psychiatric condition or substance use problem that would make it difficult to follow the study requirements.
• You are not able to attend the required visits or procedures for the study.
• You are currently taking part in another clinical trial or have received an experimental treatment within the past 4 weeks.
• You are allergic to any of the ingredients in the study drugs.
• You are currently being treated for a different type of cancer.
• You have recently had a bacterial infection and have not yet finished your course of antibiotics.
• You have recently had COVID-19 and have not yet fully recovered.
• You are taking certain medications that can interfere with the study drug (for example, carbamazepine or phenytoin) (confirm with trial site for full list).

Important: Always verify eligibility with the trial site directly before applying.