Phase 1 Brain Cancer Trial, Recruiting

Written by an AI model from the 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 are 18 years of age or older at the time of signing the consent form.
• People who have been diagnosed with Grade IV Glioblastoma or Gliosarcoma (a specific type of aggressive brain tumour), as classified under the 2021 WHO system, including a molecular GBM diagnosis; people with a returning or worsening tumour must have already received radiation therapy, with or without chemotherapy.
• People whose tumour has tested negative for a gene change called IDH mutation, confirmed by an approved laboratory test available at the time of consent.
• People whose tumour shows amplification (extra copies) of the EGFR gene, confirmed by an approved laboratory test at the time of consent.
• People whose tumour can be measured on scans before surgery, according to standard brain tumour measurement guidelines (for certain groups in the trial only; there is no requirement for measurable disease after surgery).
• People who are able to undergo MRI scans.
• People who have had no more than 2 previous treatment courses for their tumour (for certain groups in the trial only).
• People who have recovered from serious side effects of previous treatments, and who have waited the required amount of time since their last treatment: at least 12 weeks since finishing radiation therapy; at least 6 weeks since certain chemotherapy drugs called nitrosoureas; at least 3 weeks since other chemotherapy drugs; at least 4 weeks since experimental (non-approved) treatments; at least 6 months since the last dose of a drug called bevacizumab; and at least 2 weeks or 5 half-lives (whichever is shorter) since other non-cell-killing treatments.
• People who are already scheduled for surgery as determined necessary by their treating doctors, and whose surgeon expects to be able to safely remove at least 500 mg of tumour tissue without causing significant neurological harm (for certain groups in the trial only).
• People for whom preserved tumour tissue (stored in paraffin wax) from the original diagnosis surgery is available — either one tissue block or at least 10 prepared slides.
• People who are able to care for themselves with occasional help from others (a level of physical function known as Karnofsky Performance Status of 60% or higher).
• People whose blood counts and organ function meet the required levels, including adequate white blood cell count, platelets, haemoglobin, liver function, kidney function, and blood clotting measures (confirm specific values with the trial site).
• People whose heart scan (echocardiogram) shows the heart is pumping at 50% or better efficiency, with no significant heart concerns identified by the investigator; if an echocardiogram cannot be done, an alternative heart scan may be considered after discussion with the treating doctor.
• People whose heart rhythm test (ECG) done within 2 weeks before starting treatment shows a normal heart rate-corrected interval (QTc below 450 milliseconds) with no significant abnormalities (for certain groups in the trial only).
• Women who could become pregnant must have a negative blood pregnancy test before entering the study and must agree to use effective contraception from the start of the study until at least 4 months after the last dose of study treatment; women who become pregnant or think they might be pregnant during the study must inform their treating doctor immediately.
• All female participants (except those who are post-menopausal) must have a negative blood pregnancy test at screening and a negative urine pregnancy test at the start of treatment.
• Female participants must be either post-menopausal, permanently surgically unable to have children, or using at least one approved method of contraception from the first day of the study until at least 4 months after the last dose of treatment.
• Male participants who are sexually active with female partners who could become pregnant must use approved contraception from the first day of the study until at least 4 months after the last dose of treatment.
• Female participants must not be pregnant, breastfeeding, or planning to become pregnant during the study or for at least 4 months after the last dose of treatment.
• Male participants must not be planning to father a child or donate sperm during the study or for at least 4 months after the last dose of treatment.
• People with no currently active hepatitis B, hepatitis C, or HIV infection — though people whose hepatitis B or C is considered fully cured, or people with HIV whose virus is undetectable and whose HIV medications are unlikely to interact with the study drugs, may be considered at the investigator's discretion.
• People who do not have another active cancer requiring treatment at the time of enrolment.
• People who are able to swallow tablets or medication dissolved in liquid.

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have had a significant allergic reaction to drugs chemically similar to the study treatments.
• People who have previously been treated with drugs that target the EGFR gene, unless a later surgery confirmed the EGFR alteration was still present in the tumour after that treatment.
• People currently taking a specific type of anti-seizure medication known as enzyme-inducing anti-epileptic drugs (EIAEDs); people who previously took these medications may be considered if they have been off them for at least 10 days before the first study dose.
• People who have significant problems with blood, kidney, or liver function, or who have significant bleeding in the brain that could affect the quality of tissue collected during surgery.
• People with uncontrolled ongoing health conditions such as severe high blood pressure, active infection, serious heart failure, unstable chest pain, heart rhythm problems, or mental health or social circumstances that would make it difficult to follow the study requirements.
• People with significant heart or cardiovascular problems, including: a recent history (within the past 6 months) of heart failure, a heart attack or cardiovascular event, heart rhythm problems requiring medication or surgery, fluid around the heart, or heart inflammation; significant abnormalities in heart rhythm or electrical conduction seen on a resting ECG; or any condition or medication that increases the risk of abnormal heart rhythms (confirm with trial site).
• People with a significant medical or psychiatric condition that, in the investigator's opinion, would interfere with participation or make them unsuitable for the study.
• People who are pregnant or breastfeeding, due to potential risks to an unborn baby or infant from the study treatments.
• People who are HIV-positive and taking certain medications (strong CYP3A4 inducers or inhibitors) that could interact with the study drugs.
• People with active liver or bile duct disease that is currently being treated with antiviral medications (with some exceptions, such as a condition called Gilbert's syndrome, asymptomatic gallstones, stable chronic liver disease, or liver spread from the brain tumour, as assessed by the investigator).
• People taking certain medications that affect how drugs are transported in the body (known as P-gp inhibitors or P-gp substrates with a narrow therapeutic index).
• People taking medications that are known to cause a specific type of heart rhythm change (QTc prolongation), if the QTc measurement is 460 milliseconds or above (a common chemotherapy called temozolomide is allowed for certain groups in the trial).
• People who have taken moderate or strong CYP3A inhibitors (drugs that affect how the body breaks down certain medicines) within the 10 days before the first study dose, or who would need to take them during the study.
• People who have received a live vaccine within 2 weeks before the first study dose, or who are expected to need a live vaccination during the study or within 4 weeks after the last dose.

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