BridgeMD
New treatment option for Gastrointestinal Stromal Tumors
Official title Imatinib TDM in GIST
ClinicalTrials.gov ID: NCT05493215
What this study is testing
What is Imatinib?
Imatinib is an investigational medicine, being studied as a potential treatment for gastrointestinal stromal tumors.
Also referred to as Gleevec.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lexington, Kentucky, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lexington, Kentucky, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.