OncoMatch/Clinical Trials/NCT05366816
ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
Official title: ctDNA-Guided Sunitinib And Regorafenib Therapy for Gastrointestinal Stromal Tumor (GIST)
Is NCT05366816 recruiting? Yes, currently enrolling (Oct 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
Treatments studied
Targeted therapy
Cancer type
Gastrointestinal Stromal Tumor
Biomarker criteria
Excluded: KIT wild-type
Patients who are known to be KIT wild type.
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. Additionally, disease progression or intolerance to other systemic therapies including investigational agents and radiotherapy is allowed. Patients who experienced intolerance to prior therapies must have objective disease progression prior to enrollment.
Cannot have received: sunitinib (sunitinib)
Patients who have received prior treatment with sunitinib or regorafenib.
Cannot have received: regorafenib (regorafenib)
Patients who have received prior treatment with sunitinib or regorafenib.
Cannot have received: tyrosine kinase inhibitor
Exception: If a patient receives the same TKI more than once sequentially (eg, imatinib followed by a period without systemic therapy and retreatment with imatinib), that will be counted as a single TKI treatment regimen.
Patients who have received more than 2 different prior tyrosine kinase inhibitor (TKI) treatment regimens.
Lab requirements
Blood counts
Platelet count < 90 × 10^9/L and absolute neutrophil count (ANC) < 1.0 × 10^9/L. Hemoglobin < 9 g/dL.
Kidney function
Estimated (Cockcroft-Gault formula) or measured creatinine clearance < 40 mL/min.
Liver function
AST/ALT > 3 × ULN if no hepatic metastases are present; > 5 × ULN if hepatic metastases are present. Total bilirubin >1.5 × ULN; in presence of Gilbert's syndrome, total bilirubin > 3 × ULN or direct bilirubin > 1.5 × ULN.
Patients who have poor organ function as defined by one or more of the following laboratory parameters: ... (see full text for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Miami · Miami, Florida
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05366816 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior sunitinib, regorafenib, tyrosine kinase inhibitor disqualifies patients from enrollment.
Are patients with KIT alterations eligible?
No. KIT wild-type is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages