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