Actively Recruiting
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Led by University of Miami · Updated on 2025-09-09
48
Participants Needed
1
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older
- Histologically confirmed metastatic or unresectable GIST confirmed by an experienced surgeon
- Prior treatment with imatinib showing disease progression, inadequate benefit, or intolerance
- Disease progression or intolerance to other systemic therapies including investigational agents and radiotherapy allowed
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
- Informed consent provided by patient or legal guardian
- Presence of KIT exon 13 or 17 secondary mutation confirmed by ctDNA blood test or biopsy
You will not qualify if you...
- Previous treatment with sunitinib or regorafenib
- More than two different prior tyrosine kinase inhibitor (TKI) regimens received
- Known to be KIT wild type
- Systemic anticancer therapy within 2 weeks before enrollment or recent radiotherapy to major organs within 2 weeks
- Clinically significant uncontrolled cardiovascular disease including recent heart failure, myocardial infarction, unstable angina, or uncontrolled hypertension
- Recent arterial or venous thrombotic or embolic events within specified time frames
- Recent severe hemorrhage or bleeding events within 4 weeks
- Known risk of intracranial bleeding or history of intracranial bleeding within 1 year
- Non-healing wounds, ulcers, or bone fractures
- Poor organ function defined by specific laboratory test thresholds
- Recent neutrophil growth factor support within 14 days
- Need for strong CYP3A4 inhibitors or inducers
- Major surgery within 14 days or significant traumatic injury within 28 days
- History of another primary malignancy requiring treatment within 2 years with specific exceptions
- History of seizure disorder requiring medication
- Brain metastases
- Inability or unwillingness to comply with study procedures
- QTcF interval greater than 450 msec
- Women not postmenopausal or surgically sterile unwilling to use contraception; men unwilling to use contraception as specified
- Pregnant or breastfeeding women
- Clinically significant medical conditions or laboratory abnormalities affecting safety or study results
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
L
Leonela Wright
CONTACT
J
Jonathan Trent, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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