| NCT ID | NCT05493215 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Reema A. Patel |
| Condition | Gastrointestinal Stromal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2024-03-26 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 28 participants in total. It began in 2024-03-26 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V) * Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month * Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease * Age ≥18 years * ECOG performance status of 0 or 1 * Normal organ function Exclusion Criteria: * Presence of PDGFRA D842V mutation * Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug * Concomitant anticoagulation with oral warfarin. * Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6 * Uncontrolled intercurrent illness * Concurrent malignancy
Contact & Investigator
Reema Patel, MD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT05493215 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Stromal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05493215 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05493215 currently recruiting?
Yes, NCT05493215 is actively recruiting participants. Contact the research team at Yvonne.Taul@uky.edu for enrollment information.
Where is the NCT05493215 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT05493215 clinical trial?
NCT05493215 is sponsored by Reema A. Patel. The principal investigator is Reema Patel, MD at University of Kentucky. The trial plans to enroll 28 participants.