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NCT05669339 · ClinicalTrials.gov registry record · Phase 2
AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma
A Phase 2 study of Hepatocellular Carcinoma, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05669339: Recruiting Phase 2 study of Hepatocellular Carcinoma, sponsored by University of Florida.
NCT05669339 is a Phase 2 study of Hepatocellular Carcinoma that is actively recruiting participants, run by University of Florida. The registered enrollment target is 12 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05669339, a Phase 2 study of Hepatocellular Carcinoma, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will test the hypothesis that a novel combination of three drugs (sorafenib, sonidegib, and irinotecan), in conjunction with individually optimized doses, can be safely administered and lead to improved clinical outcomes in patients with hepatocellular carcinoma compared to standard of care. The main objective of this study is to establish safe dose ranges for the coadministration of sorafenib, sonidegib, and irinotecan in patients with hepatocellular carcinoma. Furthermore, we will collect data to inform the application of an artificial intelligence/computational approach to individual dosing of combination chemotherapy. Individualization of dosing will be achieved by using Phenotypic Personalized Medicine (PPM) to maximize treatment efficacy in patients with hepatocellular carcinoma, while minimizing toxicity. Drug efficacy will be assessed by measuring plasma circulating tumor DNA (ctDNA). Toxicity will be assessed by quantitating organ injury and patient tolerability. Recommended dosing for future studies will be based on the totality of the data.
Primary Outcome
Determine the maximum tolerated dose of irinotecan, sonidegib, and sorafenib
Conditions Studied
Interventions
- DRUG Irinotecan
- DRUG Sorafenib
- DRUG Sonidegib
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2024-12-02 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What NCT05669339 shows while recruiting
NCT05669339 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Irinotecan is the first listed.
NCT05669339 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05669339 about?
NCT05669339 is a clinical study titled "AD HOC Trial: Artificial Intelligence-Based Drug Dosing In Hepatocellular Carcinoma". This study will test the hypothesis that a novel combination of three drugs (sorafenib, sonidegib, and irinotecan), in conjunction with individually optimized doses, can be safely administered and lead to improved clinical outcomes in patients with hepatocellular carcinoma compared to standard of ca...
What is the current status of trial NCT05669339?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2024-12-02. Estimated completion is 2026-04.
What conditions does trial NCT05669339 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT05669339?
The interventions under investigation include: Irinotecan (DRUG), Sorafenib (DRUG), Sonidegib (DRUG).
Who is sponsoring clinical trial NCT05669339?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05669339 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05669339's enrollment target sits among peer trials
12 137th of 145 higher than 7 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma 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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