Phase 2 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:

• Adults aged 18 or older
• People who have been newly diagnosed with glioblastoma (a type of brain tumour), confirmed through laboratory analysis of tumour tissue, classified according to the 2021 WHO brain tumour guidelines
• People whose tumour has been tested for a specific genetic marker called MGMT methylation, or who have tumour tissue available so that test can be done
• 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 treating doctor plans to give them the standard course of radiotherapy (60 Gy in 1.8–2 Gy doses) combined with chemotherapy using a drug called temozolomide, followed by six further cycles of temozolomide, in line with established European brain tumour treatment guidelines
• Women who are not able to become pregnant, or women who are able to become pregnant and have a negative pregnancy test within 14 days of starting treatment, and who agree to use highly effective contraception from the start of the study until 6 months after the last dose of study medication
• Men who are able to father children and agree to use two forms of contraception throughout the study and for 6 months after the last dose of study medication
• People who have read and signed an informed consent form confirming they have been told about all relevant aspects of the study
• People who are willing and able to attend scheduled visits and follow all required study procedures

Who may not be able to join:

• People who have already received any treatment for their newly diagnosed glioblastoma other than surgery
• People whose treating doctor plans to use tumour-treating fields (a device-based treatment) as part of their care
• People who are unable to have a contrast-enhanced MRI scan
• People whose blood counts, kidney function, or liver function fall below the levels required for safe participation — including low white blood cell counts, low platelet counts, low haemoglobin, reduced kidney function, or elevated liver enzymes (confirm with trial site for specific values)
• People with any serious other medical condition that, in the opinion of the trial doctor, would make participation unsafe or make it difficult to follow the study requirements
• People who have a known medical reason why they cannot take the study drug vortioxetine
• People with a documented history of certain mental health conditions, including major depression, bipolar disorder, obsessive-compulsive disorder, schizophrenia, a history of suicidal thoughts or attempts, thoughts of harming others, or active severe personality disorders
• People who are currently pregnant or breastfeeding
• People with an active, uncontrolled infection or other serious illness that, in the opinion of the trial doctor, would put them at undue risk or affect the study
• People who currently have another cancer, unless they have been free of that cancer without any treatment for at least one year
• People who need to take other anti-cancer treatments at the same time as the study medication

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