Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
Study NCT ID:
NCT05635734
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-11-18
First Post:
2022-11-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Azeliragon and Chemoradiotherapy in Newly Diagnosed Glioblastoma
Sponsor:
Cantex Pharmaceuticals
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2022-002801-36 | EUDRACT_NUMBER | None | View |