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NCT05366816 · ClinicalTrials.gov registry record · Phase 2
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
A Phase 2 study of Gastrointestinal Stromal Tumors, sponsored by University of Miami.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 48
- Enrollment target
- 1
- Study location
NCT05366816: Recruiting Phase 2 study of Gastrointestinal Stromal Tumors, sponsored by University of Miami.
NCT05366816 is a Phase 2 study of Gastrointestinal Stromal Tumors that is actively recruiting participants, run by University of Miami. The registered enrollment target is 48 participants, below the 90-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (47% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05366816, a Phase 2 study of Gastrointestinal Stromal Tumors, is actively recruiting participants, sponsored by University of Miami.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 48 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.
Primary Outcome
The overall response rate (ORR) will be defined as the number of evaluable patients whose best overall response to study treatment is complete response (CR) or partial response (PR). ORR will be assessed using Choi criteria by treating physician.
Conditions Studied
Interventions
- DRUG Sunitinib
- DRUG Regorafenib
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT05366816 shows while recruiting
NCT05366816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 90-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (47% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumors appearing as the primary indexed condition, and to 2 interventions - of which Sunitinib is the first listed.
NCT05366816 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05366816 about?
NCT05366816 is a clinical study titled "ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST". The purpose of this research is to test if mutations (changes in DNA) in exons (segment of DNA or RNA containing information that has the instructions for making proteins) in the KIT gene can be used to predict the body's response to standard of care treatment.
What is the current status of trial NCT05366816?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 48 participants. The study started on 2023-10-17. Estimated completion is 2028-12-31.
What conditions does trial NCT05366816 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT05366816?
The interventions under investigation include: Sunitinib (DRUG), Regorafenib (DRUG).
Who is sponsoring clinical trial NCT05366816?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05366816 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
Similar trials for Gastrointestinal Stromal Tumors
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05366816's enrollment target sits among peer trials
48 5th of 10 higher than 6 of 10 other Gastrointestinal Stromal Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Stromal Tumors 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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