ctDNA-Guided Sunitinib and Regorafenib Therapy for GIST

This study is looking at how well Sunitinib and Regorafenib work for people with gastrointestinal stromal tumors (GIST). Researchers want to see if changes in a gene called KIT can help predict how you'll respond to these standard treatments. You might be able to join if you are 18 or older, have GIST that has spread or can't be removed by surgery, and have already received imatinib treatment but it wasn't effective or you couldn't tolerate it. The main goal is to see how many participants have their tumors shrink or disappear within 12 months. The current status of this study is unclear.

Study design: This is an interventional study with a planned enrollment of 48 participants. The phase of the study is not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: The primary endpoint is measured at up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST

Recruiting

PHASE2Ages 18+InterventionalTreatment

University of Miami

~48 participants

Updated 2025-09-09 on ClinicalTrials.gov

What's tested:SunitinibRegorafenib

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Number of Participants Achieving Overall Response

Measured over Up to 12 months

Conditions

Gastrointestinal Stromal Tumors

Where it's being run

1 sites across 1 states

Florida1

Study leadership

Jonathan Trent, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Miami

Who to contact

Leonela Wright

[email protected]

305-243-0864

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

Persistent proteinuria of NCI-CTCAE version 4.03 Grade 3 or higher

Alanine aminotransferase and aspartate aminotransferase (AST) \> 3 × upper limit of normal (ULN) if no hepatic metastases are present; \> 5 × ULN if hepatic metastases are present.

Total bilirubin \>1.5 × ULN; and in presence of Gilbert's syndrome, total bilirubin \> 3 × ULN or direct bilirubin \> 1.5 × ULN.

Estimated (Cockcroft-Gault formula) or measured creatinine clearance \< 40 mL/min.

Platelet count \< 90 × 109/L and absolute neutrophil count (ANC) \< 1.0 × 10\^9/L.

Hemoglobin \< 9 g/dL. Transfusion and erythropoietin may be used to reach at least 9 g/dL, but must have been administered at least 2 weeks before screening. 11. Patients who have received neutrophil growth factor support within 14 days of screening. 12. Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4. 13. Patients who have had a major surgical procedure (minor surgical procedures such as central venous catheter placement, tumor needle biopsy, and feeding tube placement are not considered major surgical procedures) within 14 days of screening. Patient has significant traumatic injury within 28 days before screening. 14. Patients who have a history of another primary malignancy that has been diagnosed or required therapy within 2 years before screening. (The following are exempt from the 2-year limit: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate cancer, and completely resected carcinoma in situ of any site.) 15. Patients who have a history of a seizure disorder requiring anti-seizure medication. 16. Patients who have metastases to the brain. 17. Patients who are unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions. 18. Patients who have a QT interval corrected using Fridericia's formula (QTcF) of \> 450 msec. 19. Women who are unwilling, if not postmenopausal or surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 30 days after the last dose of study drug. Men who are unwilling, if not surgically sterile, to abstain from sexual intercourse or employ highly effective contraception from the time of randomization and for at least 90 days after the last dose of study drug. Refer to Appendix G for acceptable methods of contraception. 20. Women who are pregnant, as documented by a serum beta human chorionic gonadotropin (β-hCG) pregnancy test consistent with pregnancy, obtained within 7 days before the treatment assignment. Females with β-hCG values that are within the range for pregnancy but are not pregnant (false positives) may be enrolled with written consent of the investigator, after pregnancy has been ruled out. Females of non-childbearing potential (postmenopausal for more than 1 year; bilateral tubal ligation; bilateral oophorectomy; hysterectomy) do not require a serum β-hCG test. 21. Women who are breastfeeding. 22. Patients who have prior or ongoing clinically significant illness, medical condition, surgical history, physical finding, or laboratory abnormality that, in the Investigator's opinion, could affect the safety of the patient; alter the absorption, distribution, metabolism, or excretion of the study drug; or impair the assessment of study results. 23. Patients with impaired decision-making capacity.

What this trial measures

Number of Participants Achieving Overall ResponseUp to 12 months
The overall response rate (ORR) will be defined as the number of evaluable patients whose best overall response to study treatment is complete response (CR) or partial response (PR). ORR will be assessed using Choi criteria by treating physician.

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