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:

• People aged 6 months to 25 years (inclusive) who have at least two generations of Japanese ancestry, at the time of signing the consent form.
• People who have a low-grade brain tumour (glioma) that has come back or continued to grow, and whose tumour has been confirmed by laboratory testing to have a specific gene change involving BRAF (either a BRAF V600 mutation or a KIAA1549:BRAF fusion).
• People whose tumour has been confirmed as cancerous by a tissue sample, either at the time of original diagnosis or when the tumour returned.
• People who have already received at least one round of systemic (whole-body) cancer treatment and whose scans show the tumour has grown or progressed.
• People who have at least one tumour area visible and measurable on a brain scan, with that scan taken within 28 days before starting treatment (confirm with trial site for exact imaging requirements).
• People who have fully recovered from the immediate side effects of any previous cancer treatments.
• People whose ongoing side effects from prior cancer treatment are mild and stable (rated at a certain level or below on a standard medical scale), with any ongoing eye-related side effects being very mild.
• People whose blood, liver, and kidney test results are within acceptable ranges.
• People taking steroids for tumour-related symptoms who have been on a stable dose for at least 14 days before starting the trial.
• People who are able to swallow tablets or liquid, or receive the medication through a feeding tube of an appropriate size.

Who may not be able to join:

• People whose tumour has additional known gene changes beyond the BRAF alteration, such as certain mutations affecting histones, IDH1/2, FGFR, MYBL, or NF1 genes (confirm with trial site for the full list).
• People who appear to be getting worse based on symptoms alone, without any scan evidence showing the tumour has grown or returned.
• People who have a known or suspected diagnosis of neurofibromatosis type 1 (a genetic condition), based on genetic testing or standard diagnostic criteria.
• People who have a history of a serious medical condition — other than the brain tumour being studied — that the trial doctor believes could make participation unsafe (for example, a confirmed or suspected lung disease affecting the tissue between air sacs).
• People who have a history or current signs of certain eye conditions affecting the retina (such as central serous retinopathy or retinal vein occlusion), or other eye findings that could increase risk of these conditions. Note: eye problems already known to be caused by a long-standing tumour on the optic pathway (such as vision loss or a squint) are not considered a reason to exclude someone from this trial.
• People who have had major surgery within 14 days before starting the trial (routine procedures such as placement of a venous line, cyst drainage, or a brain shunt are not included in this restriction).
• People with serious heart or blood vessel problems, including a heart attack, a blood clot in a vein or the lungs within the past 6 months, ongoing heart muscle disease, or an abnormal heart rhythm reading on an ECG.
• People with significant nausea and vomiting, difficulty absorbing nutrients, or who have had substantial portions of their stomach or bowel removed in a way that could prevent the trial medication (tovorafenib) from being properly absorbed.
• People who have uncontrolled seizures or are otherwise neurologically unstable despite receiving appropriate treatment.
• People who are taking certain medications that strongly affect the way the body processes the trial drug, or certain other medications with a narrow safe dosage range, within 14 days before starting the trial (confirm with trial site for the specific medications involved).
• People who have significant skin problems at the screening stage that the trial doctor believes could increase the risk of serious skin side effects from the trial medication.

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