Gastrointestinal Stromal TumorsPhase 2NCT05493215
Imatinib TDM in GIST
A Phase 2 study testing Imatinib in people with Gastrointestinal Stromal Tumors, run by Reema A. Patel at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Imatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2024to Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Markey Cancer Center
Lexington, Kentucky, 40536
Yvonne Taul, RN, 859-323-7628, yvonne.taul@uky.edu
About this study
Official title: A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
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.
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Imatinib
- Medical subject headings
- Gastrointestinal Stromal Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImatinibDrug
Also called Gleevec
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Imatinib TDM | Experimental | Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib. Receives: Drug: Imatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
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.
Measured: 6 months
Secondary outcomes (3)
Percent of patients achieving therapeutic levels of imatinib.
Percent of patients achieving therapeutic levels of imatinib.
Measured: 6 months
Quality of Life based on the EORTC QLQ-C30
Quality of Life will be assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. It incorporates five functional scales, three symptom scales, a global health status, financial impact, and single items assessing additional symptoms. All scales and single-item measures are transformed so that scores range from 0-100; higher scores represent a higher response level.
Measured: 6 months
Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start26 Mar 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reema A. Patel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reema A. Patel, University of Kentucky
- Investigators
- Reema Patel, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05493215
- Sponsor's protocol ID
- MCC-23-GI-131
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2022
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
- ClinicalTrials.gov ID
- NCT05493215
- Acronym / sponsor ID
- MCC-23-GI-131
- Conditions
- Gastrointestinal Stromal Tumors
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Reema A. PatelUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 9 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imatinib TDM | Experimental | Drug: ImatinibPatients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ImatinibAlso: GleevecTherapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms. | Drug | Imatinib TDM |
Primary outcome
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
Time frame: 6 months
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.
3 secondary outcomes
Percent of patients achieving therapeutic levels of imatinib.
Time frame: 6 months
Quality of Life based on the EORTC QLQ-C30
Time frame: 6 months
Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years
Time frame: 3 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Gastrointestinal Stromal Neoplasms
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ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
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A Prospective, Randomized, Multicenter, Comparative Study of the Efficacy of Imatinib Resumption Combined With Atezolizumab Versus Imatinib Resumption Alone in Patients With Unresectable Advanced Gastrointestinal Stromal Tumors (GIST) After Failure of Standard Treatments
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Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)
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A Study of Inlexisertib (DCC-3116) in Combination With Anticancer Therapies in Participants With Advanced Malignancies
GIST
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reema Patel, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Imatinib in people with Gastrointestinal Stromal Tumors, run by Reema A. Patel at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yvonne A Taul, RN (859-323-2354, Yvonne.Taul@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.