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:

• Children and teenagers aged 12 months to under 18 years old (for the dose escalation phase), or aged 12 months to under 22 years old (for the disease expansion phase) at the time of joining the study.
• People with a newly diagnosed high-grade brain tumour, diffuse midline glioma (a type of tumour found in the middle of the brain), or diffuse intrinsic pontine glioma (DIPG, a tumour in the brainstem), where the treating team has determined the person is suitable to receive a standard course of radiation therapy.
• People whose tumour has been confirmed by a tissue biopsy, except in certain DIPG cases where the tumour's appearance on brain scans meets specific criteria and a biopsy may not be required (confirm with trial site).
• People whose tumour is measurable on scans, or where the tumour was fully removed by surgery and cannot currently be measured.
• People with a level of physical functioning at or above a certain threshold, as rated by medical staff using standard performance scales (confirm with trial site).
• People who have only received surgery and/or steroid medications as prior treatment — no previous chemotherapy or radiation therapy for any cancer is permitted.
• People whose blood counts meet the required levels: sufficient white blood cells, platelets (without recent transfusions), and haemoglobin (red blood cell protein), tested within 7 days before joining.
• People whose kidney function, measured through blood or urine tests, meets the required levels for their age and sex, tested within 7 days before joining.
• People whose liver function tests (bilirubin, ALT, AST, and albumin) are within acceptable ranges, tested within 7 days before joining.
• People who are not breathless at rest, have no difficulty with physical exertion, and have an adequate oxygen level in their blood.
• People with a seizure condition may be considered if their seizures are well controlled on medication, with no increase in seizure frequency in the 7 days before joining.
• People whose blood lipase (a pancreas-related enzyme) and blood clotting levels are within acceptable ranges, tested within 7 days before joining.
• People who are able to swallow tablets whole, as the study drug cannot be given through a feeding tube.
• People living with HIV may be considered if they are on effective HIV treatment with an undetectable viral load within the past 6 months, provided their HIV medications do not interact with the study drug (confirm with trial site).

Who may not be able to join:

• People who are pregnant or breastfeeding, or those who are able to have children and are unwilling to use two effective forms of contraception for the duration of the study and for a specified period after the last dose of the study drug.
• People who are currently taking another experimental (investigational) drug.
• People who are currently receiving other anti-cancer treatments, with the exception of steroid medications.
• People who are taking medications to prevent organ rejection after a bone marrow transplant (such as cyclosporine or tacrolimus).
• People who are currently taking certain medications that strongly affect how the body processes the study drug (specific enzyme-affecting drugs called strong CYP3A4 inhibitors or inducers), or who have taken certain anti-seizure medications of this type within 14 days before joining.
• People who have an infection that is not under control.
• People who have previously received a solid organ transplant (such as a kidney or liver transplant).
• People whose condition is declining quickly, or who in the medical team's judgement may not be able to safely follow the study's requirements.
• People who have a medical condition that affects how the body absorbs medications, such as a condition where part of the intestine is missing or shortened.
• People with known macular degeneration (a serious eye condition), uncontrolled glaucoma, or cataracts.
• People whose primary tumour is located in the spinal cord rather than the brain.
• People whose cancer has spread to other parts of the brain, spine, or the fluid surrounding the brain and spinal cord.
• People whose tumour has spread across three or more lobes of the brain (with a specific exception for certain thalamic tumours — confirm with trial site).
• People with a specific tumour type called infant-type hemispheric high-grade glioma.
• People whose tumour has a specific genetic change called a BRAF V600E mutation.
• People who are unable to receive the radiation therapy required by the study.
• People who have previously received radiation therapy as part of cancer treatment.
• People who have a muscle disease (myopathy) or whose blood levels of a muscle enzyme called CK are significantly and repeatedly elevated on testing at the start of the study.
• People with signs of significant heart problems or an abnormal heart rhythm measurement (QTc interval above 450 milliseconds) on a heart tracing (ECG) taken before joining.
• People with a known hepatitis B or C infection where the virus is detectable in the blood.
• People with any other significant medical condition that the treating doctor believes would make it unsafe to take the study drug or participate in the study.

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