OncoMatch/Clinical Trials/NCT05366816
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Is NCT05366816 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Sunitinib and Regorafenib for gastrointestinal stromal tumors.
Treatment: Sunitinib · Regorafenib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Required: KIT wild-type
Patients who are known to be KIT wild type.
Allowed: KIT exon 13 secondary mutation
Presence of proto-oncogene c-KIT (KIT) exon 13 or 17 secondary mutation will be determined through a circulating tumor DNA (ctDNA) blood test or biopsy performed as per standard of care.
Allowed: KIT exon 17 secondary mutation
Presence of proto-oncogene c-KIT (KIT) exon 13 or 17 secondary mutation will be determined through a circulating tumor DNA (ctDNA) blood test or biopsy performed as per standard of care.
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: tyrosine kinase inhibitor (imatinib)
Patients who received imatinib prior treatment regimens, including adjuvant therapy, with objective disease progression, inadequate clinical benefit, or intolerance.
Cannot have received: tyrosine kinase inhibitor (sunitinib, regorafenib)
Patients who have received prior treatment with sunitinib or regorafenib.
Lab requirements
Blood counts
Platelet count < 90 × 10^9/L and absolute neutrophil count (ANC) < 1.0 × 10^9/L. Hemoglobin < 9 g/dL. Persistent proteinuria of NCI-CTCAE version 4.03 Grade 3 or higher.
Kidney function
Estimated (Cockcroft-Gault formula) or measured creatinine clearance < 40 mL/min.
Liver function
AST and ALT > 3 × 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.
Cardiac function
QTcF > 450 msec. Clinically significant, uncontrolled, cardiovascular disease, including congestive heart failure Grades II, III or IV according to the New York Heart Association classification, myocardial infarction or unstable angina within the previous 6 months, or uncontrolled hypertension.
Patients who have poor organ function as defined by one or more of the following laboratory parameters: Persistent proteinuria of NCI-CTCAE version 4.03 Grade 3 or higher; AST/ALT > 3 × 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 × 10^9/L and absolute neutrophil count (ANC) < 1.0 × 10^9/L. Hemoglobin < 9 g/dL. QTcF > 450 msec. Clinically significant, uncontrolled, cardiovascular disease, including congestive heart failure Grades II, III or IV according to the New York Heart Association classification, myocardial infarction or unstable angina within the previous 6 months, or uncontrolled hypertension.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
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