Stopped: Terminated due to the sponsor's decision.
This is a randomized, open-label, phase 2 study evaluating the safety and efficacy of oral ropidoxuridine as a radiation-sensitizing agent in patients with newly diagnosed wild-type isocitrate dehydrogenase glioblastoma with an unmethylated O6-methylguanine-DNA methyltransferase promoter, undergoing standard 60 Gy radiotherapy.
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Number of patients treated with oral ropidoxuridine at dose levels of 960 and 1200 mg once daily, with treatment-related adverse events assessed by CTCAE v5.0.
Timeframe: From the first day of treatment start until 30 days after treatment completion
adiographic response rate, disease control rate, best overall response, and duration of overall response in patients treated with oral ropidoxuridine at 960 and 1200 mg daily doses, assessed using the Response Assessment in Neuro-Oncology criteria.
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Timeframe: he first 36 days of treatment.
Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily
Timeframe: The first 36 days of treatment.
Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Timeframe: The first 36 days of treatment.
Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Timeframe: The first 36 days of treatment.
Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily.
Timeframe: The first 36 days of treatment.