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NCT05798507 · ClinicalTrials.gov registry record · Early Phase 1
Identification of Treatment Concentrations of Defactinib or VS-6766 for the Treatment of Patients With Glioblastoma
A Early Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Emory University.
- Active
- Registry status
- Early Phase 1
- Development phase
- 14
- Enrollment target
- 1
- Study location
NCT05798507: Active Early Phase 1 study of Glioblastoma and Recurrent Glioblastoma, sponsored by Emory University.
NCT05798507 is a Early Phase 1 study of Glioblastoma and Recurrent Glioblastoma that is active but no longer recruiting, run by Emory University. The registered enrollment target is 14 participants, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05798507, a Early Phase 1 study of Glioblastoma and Recurrent Glioblastoma, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 14 participants
- Enrollment target
- 1
- Study location
Study Summary
This early phase I trial tests brain concentration level and safety of defactinib or VS-6766 for the treatment of patients with glioblastoma. Recently, two new drugs that seem to work together have been shown to have promising treatment effects in tissue culture and animal models of glioblastoma. Each inhibits a different glioblastoma growth pathway and when used together may create a larger effect on tumor growth than either alone. Growth pathway describes a series of chemical reactions in which a group of molecules in a cell work together to control cell growth. It is known that glioblastoma tumor cells can grow because of lack of regulation. Both Pyk2 and the closely related kinase (FAK) proteins help regulate tumor cell invasion, unless they are produced in large amounts (over expressed). Specifically, Raf and FAK/Pyk2 regulation of cell division is activated quite a bit more in gliomas compared to normal tissues. Recently developed inhibitors of Raf (VS-6766) and FAK (defactinib) which belong to a class of medications called kinase inhibitors, are aimed to bring their activity to proper levels and may stop tumor growth.
Primary Outcome
Defactinib concentration will be measured in a sample of the glioblastoma, brain around the glioblastoma, and in a serum sample from each subject receiving Defactinib. Descriptive statistics, such as mean and standard deviation, will be generated with these results. Concentration will be compared between dose levels within study drug using two-sample t-tests or non-parametric equivalents such as Mann Whitney U tests.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- DRUG Avutometinib
- DRUG Defactinib
Study Locations (1)
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2023-07-28 |
| Est. Completion | 2027-12-03 |
| Phase | Early Phase 1 |
What the registry record for NCT05798507 still lists
NCT05798507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 109-participant average among 199 other Glioblastoma trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Glioblastoma appearing as the primary indexed condition, and to 3 interventions - of which Biospecimen Collection is the first listed.
NCT05798507 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05798507 about?
NCT05798507 is a clinical study titled "Identification of Treatment Concentrations of Defactinib or VS-6766 for the Treatment of Patients With Glioblastoma". This early phase I trial tests brain concentration level and safety of defactinib or VS-6766 for the treatment of patients with glioblastoma. Recently, two new drugs that seem to work together have been shown to have promising treatment effects in tissue culture and animal models of glioblastoma. Ea...
What is the current status of trial NCT05798507?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 14 participants. The study started on 2023-07-28. Estimated completion is 2027-12-03.
What conditions does trial NCT05798507 study?
This clinical trial studies the following conditions: Glioblastoma, Recurrent Glioblastoma.
What interventions are being tested in trial NCT05798507?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Avutometinib (DRUG), Defactinib (DRUG).
Who is sponsoring clinical trial NCT05798507?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05798507 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05798507's enrollment target sits among peer trials
14 176th of 199 higher than 23 of 199 other Glioblastoma trials
participants (enrollment target), bucketed by value
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