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NCT05698524 · ClinicalTrials.gov registry record · Phase 1
A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma
A Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by University of Nebraska.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT05698524: Recruiting Phase 1 study of Glioblastoma and Gliosarcoma, sponsored by University of Nebraska.
NCT05698524 is a Phase 1 study of Glioblastoma and Gliosarcoma that is actively recruiting participants, run by University of Nebraska. The registered enrollment target is 24 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05698524, a Phase 1 study of Glioblastoma and Gliosarcoma, is actively recruiting participants, sponsored by University of Nebraska.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standard therapy, radiation therapy and chemotherapy with temozolomide, few options are available. Even with further therapy, median progression free survival at 6 months after first relapse (PFS-6) is only 15%. Similarly, anaplastic astrocytoma and anaplastic oligodendroglioma, grade III gliomas, once recurrent after radiation therapy and first-line chemotherapy, have identical therapeutic options and poor outcomes with PFS-6 of 31%. Temozolomide (TMZ) has a favorable side effect profile and is available orally, however, cytotoxicity occurs. Metronomic temozolomide at low doses on a continuous schedule, have demonstrated better survival in studies. This study will determine the recommended dose and the side effects of PCI-24781/Abexinostat with metronomic temozolomide.
Primary Outcome
The incidence of adverse events (AEs) and serious adverse events (SAEs) will be recorded for each dose level cohort. Toxicities will be assessed using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Toxicities will be graded on from 1 to 5, with higher numbers indicating a higher severity grade.
Conditions Studied
Interventions
- DRUG Temozolomide
- DRUG PCI 24781
Study Locations (1)
Nebraska
- University of Nebraska Medical Center - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2023-06-26 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What NCT05698524 shows while recruiting
NCT05698524 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (78% lower).
The record links to 5 conditions, with Glioblastoma appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT05698524 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT05698524 about?
NCT05698524 is a clinical study titled "A Study of Temodar With Abexinostat (PCI-24781) for Patients With Recurrent Glioma". Glioblastoma (GBM), WHO grade IV glioma, represents the majority of adult malignant primary brain tumors, with an incidence of 2-3 per 100,000 person-years. The survival for GBM has increased in the last decade but is still low with a median survival of 15-18 months. Recurrence after initial standar...
What is the current status of trial NCT05698524?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2023-06-26. Estimated completion is 2027-03.
What conditions does trial NCT05698524 study?
This clinical trial studies the following conditions: Glioblastoma, Gliosarcoma, Anaplastic Astrocytoma, Anaplastic Oligodendroglioma, Recurrent High Grade Glioma.
What interventions are being tested in trial NCT05698524?
The interventions under investigation include: Temozolomide (DRUG), PCI 24781 (DRUG).
Who is sponsoring clinical trial NCT05698524?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05698524 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05698524's enrollment target sits among peer trials
24 141st of 199 higher than 58 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glioblastoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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