Phase 2 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:

• People who have been diagnosed with glioblastoma or gliosarcoma (specific types of brain tumour) confirmed by laboratory testing of tumour tissue, after having as much of the tumour removed by surgery as possible, where the tumour is located in the upper part of the brain.
• People who may have had a previous surgery for glioblastoma or gliosarcoma, but have not yet received any chemotherapy or radiation treatment.
• People aged 18 or older.
• People with a general health and functioning level that meets the trial's minimum requirement (a score of 60 or above on a standard medical scale called the Karnofsky Performance Scale — confirm with trial site).
• People whose blood test results show that the bone marrow, liver, and kidneys are working well enough to meet the trial's specific requirements (the trial site can advise on the exact thresholds).
• People who are able to swallow pills.
• People who are planning to start radiation therapy between 14 and 42 days after their brain surgery.
• People whose tumour has tested negative for a specific genetic marker called the IDH1 R132H mutation.
• People whose tumour has tested negative for a feature called MGMT promoter methylation (meaning the MGMT gene promoter is "unmethylated").
• People for whom certain genetic tumour data is already available or being processed, to allow the trial team to assign them to a subgroup (the trial site can advise on the specific testing required).
• People who have had, or are able to have, an MRI brain scan with contrast dye within 21 days before starting treatment — noting that only MRI scans (not CT scans) are used in this trial.
• People who are willing and able to use effective contraception (such as hormonal or barrier methods, or abstinence) throughout the trial, given that the experimental treatments may be harmful to an unborn baby. This applies to women who could become pregnant and to men whose partners could become pregnant.
• Women who could become pregnant must have a negative blood pregnancy test documented before joining the trial.
• People who are able to understand the trial and are willing to sign a written consent form.

Who may not be able to join:

• People whose brain tumour originally started as a lower-grade (less aggressive) brain tumour that later changed into glioblastoma.
• People who are planning to have a major operation during the trial.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have previously had any radiation treatment to the head or brain.
• People who are planning to use a device called Optune™ (a wearable tumour treatment device).
• People with a history of another cancer, unless they have been cancer-free for at least 2 years and are considered at low risk of that cancer returning — or unless the previous cancer was a specific, treated early-stage cancer such as cervical cancer in situ, superficial bladder cancer, or certain skin cancers (confirm with trial site).
• People with a history of bleeding within or around their brain tumour that the treating doctor considers significant.
• People with certain heart conditions, including uncontrolled heart disease, heart failure, unstable chest pain, a heart attack within the past 12 months, certain abnormal heart rhythms, a known inherited heart rhythm condition, specific electrical conduction problems in the heart, or uncontrolled high blood pressure (above 160/95 mmHg).
• People with uncontrolled diabetes, or whose fasting blood sugar is 200 mg/dL or higher, or whose HbA1c (a measure of blood sugar control over time) is 8% or higher.
• People with uncontrolled or ongoing serious illnesses such as active infection, chronic liver disease, chronic kidney disease, pancreatitis, chronic lung disease, or mental health conditions that may interfere with following the trial's requirements.
• People with known active Hepatitis B or Hepatitis C infection.
• People with known acute or chronic pancreatitis (inflammation of the pancreas).
• People experiencing significant diarrhea that has not been controlled with medication.
• People currently on antibiotics for an active infection.
• People who are pregnant or breastfeeding.
• People with significant stomach or bowel problems that could affect how the body absorbs the study medication (such as severe nausea, vomiting, uncontrolled diarrhea, or conditions affecting nutrient absorption).
• People with a known serious allergic reaction to substances similar to the experimental drugs used in this trial.
• People currently taking certain anti-seizure medications that affect how the liver processes drugs (called enzyme-inducing anti-epileptic drugs, or EIAEDs — the trial site can provide a full list). People taking these medications must have stopped them at least 7 days before starting the trial treatment.
• People currently taking medications that strongly affect a liver enzyme called CYP3A, which influences how drugs are broken down in the body. These medications must be stopped at least 7 days before starting trial treatment (confirm full list with trial site). Certain citrus fruits — including grapefruit, Seville oranges, pummelos, and related fruits — must also be avoided from 7 days before starting treatment and throughout the trial.
• People currently using certain herbal supplements, including St. John's wort, Kava, ephedra, gingko biloba, DHEA, yohimbe, saw palmetto, and ginseng. These must be stopped at least 7 days before starting treatment.
• People currently taking warfarin or similar blood-thinning medications (coumadin-type anticoagulants). These must be stopped at least 7 days before starting treatment. Certain other types of blood thinners (low molecular weight heparin and factor Xa inhibitors) are permitted.

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