Early 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 who have a new brain tumour suspected to be a glioma based on imaging, or a confirmed return of a glioma with a specific genetic change called an IDH mutation — with two groups: one for lower-grade gliomas (Arm A) and one for higher-grade gliomas (Arm B).
• People who are considered suitable candidates for surgery to remove the tumour.
• People who are 18 years of age or older.
• People who are reasonably functional in daily life, as measured by a standard performance score of 70% or above on the Karnofsky scale (confirm with trial site).
• People whose blood counts and organ function meet specific minimum levels — including adequate white blood cells, platelets, haemoglobin, liver function, kidney function, and normal blood clotting measures — without needing recent transfusions or certain blood-boosting medications to reach those levels.
• People taking anti-seizure medication, provided the dose has been stable and no seizures have occurred in the 14 days before starting the trial, and the medication is not on the trial's prohibited list.
• People taking corticosteroids at the start of the trial, provided the dose has been stable or decreasing for at least 5 days before starting (higher doses used as hormone replacement may be considered on a case-by-case basis).
• People who are willing and able to use two forms of contraception (including one barrier method) from before the trial starts, throughout participation, and for 6 months after the last dose — this applies to both women who could become pregnant and to men. Any pregnancy must be reported to the treating doctor immediately.
• People who are able to understand the trial information and are willing to sign a written consent form.

Who may not be able to join:

• People who have received bevacizumab or similar anti-VEGF treatments within the 3 months before starting the trial.
• People whose disease has spread to multiple areas of the brain, to the lining of the brain or spinal cord, or to areas outside the brain.
• People with a clinically significant abnormal heart tracing (ECG), including a specific type of irregular heart rhythm or a prolonged QT interval beyond set thresholds, or a history of a specific dangerous heart rhythm called Torsade de Pointes.
• People with swallowing difficulties, a condition affecting the gut's ability to absorb oral medications (such as short-gut syndrome or gastroparesis), or any other condition that may prevent proper absorption of tablets or capsules.
• People with active Crohn's disease or other active inflammatory bowel disease.
• People with a history of another cancer, unless all treatment for that cancer was completed at least 2 years before starting the trial and there is no current evidence of that cancer — exceptions may apply for certain skin cancers, a specific type of cervical condition, or a type of bladder cancer that has been fully treated (confirm with trial site).
• People currently being treated for another cancer, or currently taking part in another clinical trial involving an investigational treatment.
• People with a known history of allergic reactions to compounds chemically similar to the trial drug DSP-0390.
• People currently taking, or expected to take during the trial, certain medications that affect how the trial drug is processed by the body — including carbamazepine, phenytoin, phenobarbital, and other specific enzyme-affecting drugs — within 1 week or 5 half-lives before starting (whichever is longer). Note: low-dose ondansetron is permitted.
• People with any active retinal (eye) abnormality found during a screening eye examination.
• People with significant heart disease in the 6 months before starting the trial, including severe heart failure, heart attack, unstable chest pain, significant heart rhythm problems, or stroke.
• People with uncontrolled ongoing illness, including active infections, conditions causing significant immune system weakness, or mental health or social circumstances that would make it difficult to follow the trial requirements.
• People who are pregnant or breastfeeding. Women who could become pregnant must have a negative blood pregnancy test within 7 days before the first dose.
• People living with HIV whose CD4+ cell count is below 350 cells/mcL, or who have had a serious HIV-related infection in the 12 months before registration. People with HIV who are on stable, effective HIV treatment may be eligible, provided that treatment does not include any of the prohibited medications listed in the trial.
• People with a currently detectable hepatitis C viral load, or evidence of active hepatitis B infection.
• People who have had a major non-brain surgery, surgical procedure, open biopsy, or significant injury within 4 weeks before starting the trial, or who expect to need major surgery during the trial.
• People who have had a minor surgical procedure or needle biopsy within 7 days before starting the trial.
• People who have received chemotherapy or another investigational cancer treatment within 4 weeks before starting the trial (or within 6 weeks for certain drug types called nitrosoureas or immunotherapy, or 8 weeks for an implanted nitrosourea wafer).
• People who have had radiotherapy within 12 weeks before starting the trial, unless a tumour biopsy has confirmed that the cancer has returned.

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