18
Participants
Start Date
September 5, 2023
Primary Completion Date
December 31, 2024
Study Completion Date
December 31, 2025
Azeliragon 5 mg
"Azeliragon 5 mg once a day (loading initial dose for 6 days of 10 mg daily). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.~Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles."
Azeliragon 10 mg
"Azeliragon 10 mg once a day (loading initial dose for 6 days of 15 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.~Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles."
Azeliragon 20 mg
"Azeliragon 20 mg once a day (loading initial dose for 6 days of 30 mg twice a day). Patients will receive azeliragon for up to 2 years or as long as the patient and study investigator feel that a therapeutic benefit is possible.~Patients will receive involved field radiation therapy and temozolomide consisting of fractionated focal irradiation in daily fractions of 2 Gy given 5 days/week for 6 weeks, for a total of 60 Gy, plus concomitant daily temozolomide (TMZ; 75 mg/m2/day, 7 days/week from the first to the last day of radiotherapy), followed by six cycles of adjuvant TMZ (150-200 mg/m2/day for 5 days during each of six 28-day cycles."
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital del Mar, Barcelona
Hospital Clínic de Barcelona, Barcelona
Lead Sponsor
Cantex Pharmaceuticals
INDUSTRY