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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05698524
The ClinicalTrials.gov registry entry for NCT05698524 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (78% lower). The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.