protocolSection identificationModule nctId: NCT06359379, orgStudyIdInfo id: S22-11168, briefTitle: Ropidoxuridine as a Radiosensitizer in Newly Diagnosed IDH-Wildtype Glioblastoma With Unmethylated MGMT Promoter, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2026-08, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Shuttle Pharmaceuticals, Inc., class: INDUSTRY, descriptionModule briefSummary: 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., conditionsModule conditions: Glioblastoma, IDH-wildtype, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Ropidoxuridine, outcomesModule primaryOutcomes measure: 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., primaryOutcomes measure: 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., primaryOutcomes measure: Maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., primaryOutcomes measure: Trough plasma concentration of orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily, primaryOutcomes measure: Time to maximum plasma concentration for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., primaryOutcomes measure: Area under the curve for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., primaryOutcomes measure: Half-life for orally administered ropidoxuridine, at dose levels of 960 and 1200 mg once daily., secondaryOutcomes measure: Overall survival at 12 months, secondaryOutcomes measure: Radiographic Response Rate, secondaryOutcomes measure: Disease Control Rate, secondaryOutcomes measure: Best Overall Response, secondaryOutcomes measure: Duration of Response, secondaryOutcomes measure: Overall Survival, secondaryOutcomes measure: Progression-Free Survival, secondaryOutcomes measure: Six-Month Progression-Free Survival, secondaryOutcomes measure: Fraction of patients with tumor progression outside of the treatment area., secondaryOutcomes measure: Quantification of 9 relevant neurologic domains based on the NANO scale., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Lombardi Comprehensive Cancer Center at Georgetown University, city: Washington, state: District of Columbia, zip: 20007, country: United States, geoPoint lat: 38.89511, lon: -77.03637, locations facility: Sylvester Comprehensive Cancer Center, city: Miami, state: Florida, zip: 33136, country: United States, geoPoint lat: 25.77427, lon: -80.19366, locations facility: John Theurer Cancer Center at the Hackensack University Medical Center, city: Hackensack, state: New Jersey, zip: 07601, country: United States, geoPoint lat: 40.88593, lon: -74.04347, locations facility: Memorial Sloan Kettering Cancer Center, city: New York, state: New York, zip: 10065, country: United States, geoPoint lat: 40.71427, lon: -74.00597, locations facility: Allegheny General Hospital, city: Pittsburgh, state: Pennsylvania, zip: 15212, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22903, country: United States, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False