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NCT05493215 · ClinicalTrials.gov registry record · Phase 2
Imatinib TDM in GIST
A Phase 2 study of Gastrointestinal Stromal Tumors, sponsored by Reema A. Patel.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT05493215: Recruiting Phase 2 study of Gastrointestinal Stromal Tumors, sponsored by Reema A. Patel.
NCT05493215 is a Phase 2 study of Gastrointestinal Stromal Tumors that is actively recruiting participants, run by Reema A. Patel. The registered enrollment target is 28 participants, below the 92-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05493215, a Phase 2 study of Gastrointestinal Stromal Tumors, is actively recruiting participants, sponsored by Reema A. Patel.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.
Primary Outcome
To compare the incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 in patients who receive therapeutic drug monitoring (TDM) with imatinib to a historical control.
Conditions Studied
Interventions
- DRUG Imatinib
Study Locations (1)
Kentucky
- Markey Cancer Center - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-03-26 |
| Est. Completion | 2027-12 |
| Phase | Phase 2 |
What NCT05493215 shows while recruiting
NCT05493215 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 92-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Gastrointestinal Stromal Tumors appearing as the primary indexed condition, and to 1 intervention - of which Imatinib is the first listed.
NCT05493215 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT05493215 about?
NCT05493215 is a clinical study titled "Imatinib TDM in GIST". Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how...
What is the current status of trial NCT05493215?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2024-03-26. Estimated completion is 2027-12.
What conditions does trial NCT05493215 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT05493215?
The interventions under investigation include: Imatinib (DRUG).
Who is sponsoring clinical trial NCT05493215?
This trial is sponsored by Reema A. Patel, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05493215 being conducted?
This trial has 1 study location across Kentucky. 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 NCT05493215's enrollment target sits among peer trials
28 7th of 10 higher than 4 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
-
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
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-
SARC044: A Phase II Trial of Bezuclastinib in Combination With Sunitinib in Patients With GIST
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