Phase 3 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 a specific type of brain tumour called an IDH-mutant astrocytoma, grade 3 (a moderately aggressive brain tumour with a particular genetic change), confirmed by a central review team.
• People whose tumour tissue slides and samples are available for central laboratory testing to confirm the diagnosis and check for specific genetic markers.
• People whose tumour has a specific genetic mutation (in IDH1 or IDH2 genes), confirmed by the central review team.
• People whose tumour does not have a specific genetic change called CDKN2A/B homozygous deletion, as confirmed by central testing.
• People whose tumour does not have a specific genetic change called 1p/19q co-deletion, as confirmed by central testing.
• People with no sign that the tumour has spread to the spine or the lining of the brain or spinal cord.
• People who have not previously received chemotherapy, radiation to the head, IDH-inhibitor therapy, vaccine therapy, certain small-molecule treatments, or laser ablation for this tumour.
• People whose diagnostic surgery or biopsy took place no more than 6 months before joining the trial.
• People for whom the treating doctor is planning both radiotherapy and chemotherapy after surgery.
• People aged 12 years or older.
• People who are well enough to carry out basic daily activities, as measured by standard medical performance scales (confirm with trial site).
• People whose blood test results show their bone marrow, liver, and kidneys are functioning within acceptable ranges (confirm with trial site for specific values).
• People who are not pregnant and not breastfeeding; women who could become pregnant must have a negative pregnancy test within 14 days before joining.
• People who agree to use two highly effective forms of contraception (at least one being a barrier method) throughout the trial and for at least 90 days after the last dose of the study drug vorasidenib, or who are truly abstinent in line with their usual lifestyle.
• People who are not currently seriously unwell, do not have an active infection requiring treatment, and have not had an unexplained fever above 38.5°C in the 7 days before joining.
• People who have or have had another cancer, as long as that cancer or its treatment is not expected to interfere with the safety or results of this trial.
• People who are able to have an MRI scan.
• People with HIV who are on effective anti-retroviral treatment and have had an undetectable viral load within the past 6 months.
• People with chronic hepatitis B who have an undetectable viral load while on appropriate treatment.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have an undetectable viral load.
• People with heart health rated at a certain functional level or better, with no significant cardiac events (such as heart attack, stroke, or severe heart failure) in the past 6 months (confirm with trial site).

Who may not be able to join:

• People who have had significant bleeding in or around the tumour (grade 2 or higher).
• People with active inflammatory bowel disease, chronic diarrhoea, prior stomach removal surgery, swallowing difficulties, or other conditions that prevent them from taking oral medications.
• People with a known allergy or sensitivity to vorasidenib or temozolomide (the study drugs).
• People with any other serious medical condition or abnormal test result that the investigator believes would make participation unsafe or affect the reliability of trial results.
• People currently taking part in another clinical trial using an investigational treatment.
• People currently using alternating electric field therapy (also called tumour treating fields, or TTFields) for their brain tumour.
• People currently using high-dose steroids for their brain tumour (low physiologic doses for unrelated conditions may be permitted — confirm with trial site).
• People currently taking warfarin or similar blood-thinning medications; these must be stopped at least 7 days before joining (certain other blood thinners such as low molecular weight heparin may be allowed — confirm with trial site).
• People currently taking certain medications that affect how the study drug vorasidenib is processed by the body (specifically strong or moderate CYP1A2 inhibitors, moderate CYP1A2 inducers, or certain CYP3A substrates — confirm with trial site regarding specific medications).

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