Actively Recruiting
ctDNA-Guided Sunitinib And Regorafenib Therapy for Gastrointestinal Stromal Tumor (GIST)
Led by University of Miami · Updated on 2025-09-09
48
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether specific mutations in the KIT gene, particularly in exons 13 and 17, can predict how patients with gastrointestinal stromal tumors (GIST) respond to standard treatments. This Phase 2 study focuses on patients who have metastatic or unresectable GIST and have had prior treatments including imatinib. The goal is to understand how these genetic changes affect treatment outcomes with Sunitinib or Regorafenib. Participants are grouped based on their KIT gene mutation: those with exon 13 mutations receive Sunitinib orally once daily in 28-day cycles, while those with exon 17 mutations receive Regorafenib orally with a schedule of three weeks on treatment followed by one week off. If disease progresses on the initial therapy, patients may switch to the other drug. Treatment lasts for up to 12 months. During the study, researchers will monitor how many participants achieve an overall response to treatment and assess progression-free and overall survival over up to three years. They will also track clinical benefits, side effects, and treatment-related toxicities. Patients will have regular visits for assessments including blood tests to detect mutations, safety evaluations, and monitoring of treatment effects throughout the study period.
CONDITIONS
Brief Title
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Histologically confirmed metastatic or unresectable gastrointestinal stromal tumor (GIST), with unresectability confirmed by an experienced surgeon
- Prior treatment with imatinib or other systemic therapies showing disease progression, inadequate benefit, or intolerance
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2
- Provided informed consent to participate in the study
- Presence of KIT gene exon 13 or 17 mutation confirmed by circulating tumor DNA test or biopsy
You will not qualify if you...
- Prior treatment with Sunitinib or Regorafenib
- More than two prior tyrosine kinase inhibitor (TKI) treatment regimens
- Known KIT wild type status
- Recent systemic anticancer therapy within 2 weeks or recent radiotherapy within 2 weeks to major organs or 3 days to other areas
- Uncontrolled cardiovascular disease or recent heart events
- Recent thrombotic or embolic events within specified timeframes
- Recent severe bleeding events or risk of intracranial bleeding
- Non-healing wounds, ulcers, or bone fractures
- Poor organ function based on lab tests including liver, kidney, blood counts, and hemoglobin
- Recent neutrophil growth factor support
- Need for strong CYP3A4 inhibitors or inducers
- Major surgery within 14 days or significant trauma within 28 days
- History of other malignancies within 2 years except 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 using effective contraception or who are pregnant or breastfeeding
- Clinically significant illness or conditions affecting safety or study assessments
- Impaired decision-making capacity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive Sunitinib or Regorafenib based on their KIT mutation status. Treatment cycles continue for up to 12 months, with options to switch therapy upon disease progression.
Treatment cycles of 28 days with daily medication; visit frequency depends on clinical assessments
Duration - Up to 3 years
Participants are monitored for progression-free survival, overall survival, clinical benefit, and treatment-related adverse events after treatment ends.
Visits scheduled periodically during follow-up for up to 3 years
Trial Site Locations
Total: 1 location
1
University of Miami
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
L
Leonela Wright
J
Jonathan Trent, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here