NCT05635734

Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma

A Phase I/II Open Label Study to Assess Safety and Preliminary Evidence of a Therapeutic Effect of Azeliragon Combined With Conventional Concurrent Radiation and Temozolomide in Patients With Newly Diagnosed Glioblastoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Cantex Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open label study to determine the safety and preliminary evidence of a therapeutic effect of azeliragon in patients with newly diagnosed glioblastoma receiving concurrent radiation and temozolomide.

Detailed description

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. 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 be accrued in groups of six starting with Dose Level 1. Escalation will continue as described in Table 2 until stopping rules are met or the highest defined dose level is reached. If Dose Level 1 is deemed intolerable, the trial will be closed to accrual. The dose limiting toxicities (DLT) evaluation period will be defined as 28 days from initiation of dosing. The severity of adverse events will be graded according to CTCAE v 5.0. For the purpose of dose-finding, any listed AEs occurring during the DLT period, which are attributable (definite, probable, possible) to azeliragon will be classified as a DLT. In addition, the RP2/3D will take into account dose-reductions, treatment interruptions, discontinuation, and toxicities after the DLT period. RP2/3D was defined as the dose with 6 patients treated at that dose level with ≤ 1 DLT observed.

Conditions

• Glioblastoma

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-09-05
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2022-12-02
• Last updated: 2026-02-05

Locations

4 sites across 1 country: Spain