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Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma

Glioblastoma Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05635734
Study type Interventional
Source Cantex Pharmaceuticals
Contact A responsible person Designated by the Sponsor
Phone +34 93 434 44 12
Email investigacion@mfar.net
Status Recruiting
Phase Phase 1/Phase 2
Start date September 5, 2023
Completion date December 2025
View Details
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