Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma

PHASE1/PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

September 5, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2025

Conditions
Glioblastoma
Interventions
DRUG

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."

DRUG

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."

DRUG

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."

Trial Locations (4)

28034

Hospital Universitario Ramon y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

08003

Hospital del Mar, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

Sponsors
All Listed Sponsors
lead

Cantex Pharmaceuticals

INDUSTRY

NCT05635734 - Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma | Biotech Hunter | Biotech Hunter