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New treatment option for Gastrointestinal Stromal Tumors
Official title ctDNA-Guided Sunitinib And Regorafenib Therapy for GIST
ClinicalTrials.gov ID: NCT05366816
What this study is testing
What is Sunitinib?
Sunitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for gastrointestinal stromal tumors.
Also referred to as Sutent, SU11248.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients who are ≥ 18 years of age.
- Patients who have histologically confirmed metastatic or unresectable GIST. Unresectable GIST must be confirmed to be unresectable by an experienced...
- Patients who received imatinib prior treatment regimens, including adjuvant therapy, with objective disease progression, inadequate clinical benefit...
- Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
- Patient, or legal guardian if permitted by local regulatory authorities, who provides informed consent to participate in the study.
You likely can't join if
- Patients who have received prior treatment with sunitinib or regorafenib.
- Patients who have received more than 2 different prior tyrosine kinase inhibitor (TKI) treatment regimens. If a patient receives the same TKI more...
- Patients who are known to be KIT wild type.
- Patients who received any systemic anticancer therapy within 2 weeks before. Prior radiotherapy to major organs within 2 weeks of admission, or focal...
- Patients who have clinically significant, uncontrolled, cardiovascular disease, including congestive heart failure Grades II, III or IV according to...
- Patients who have experienced arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or...
See the full eligibility criteria
- Patients who are ≥ 18 years of age.
- Patients who have histologically confirmed metastatic or unresectable GIST. Unresectable GIST must be confirmed to be unresectable by an experienced surgeon.
- 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...
- Patients who have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2.
- Patient, or legal guardian if permitted by local regulatory authorities, who provides informed consent to participate in the study.
- 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.
- Patients who have received prior treatment with sunitinib or regorafenib.
- Patients who have received more than 2 different prior tyrosine kinase inhibitor (TKI) treatment regimens. If a patient receives the same TKI more than once sequentially (eg, imatinib followed by a period without...
- Patients who are known to be KIT wild type.
- Patients who received any systemic anticancer therapy within 2 weeks before. Prior radiotherapy to major organs within 2 weeks of admission, or focal radiotherapy, such as to bones, limbs, or other areas not involving...
- Patients who have clinically significant, uncontrolled, cardiovascular disease, including congestive heart failure Grades II, III or IV according to the New York Heart Association classification, myocardial infarction...
- Patients who have experienced arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), or pulmonary embolism within the 6 months before randomization or venous...
- Patients who have experienced any hemorrhage or bleeding event NCI CTCAE version 5.0 Grade 3 or higher within 4 weeks before screening.
- Patients who have a known risk of intracranial bleeding, such as a brain aneurysm or history of intracranial bleeding within 1 year prior to screening.
- Patients who have a non-healing wound, ulcer, or bone fracture.
- 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
- 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.
- Patients who have received neutrophil growth factor support within 14 days of screening.
- Patients who require therapy with a concomitant medication that is a strong inhibitor or strong inducer of CYP3A4.
- 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...
- 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...
- Patients who have a history of a seizure disorder requiring anti-seizure medication.
- Patients who have metastases to the brain.
- Patients who are unwilling or unable to comply with scheduled visits, drug administration plan, laboratory tests, or other study procedures and study restrictions.
- Patients who have a QT interval corrected using Fridericia's formula (QTcF) of \> 450 msec.
- 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...
- 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...
- Women who are breastfeeding.
- 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...
- Patients with impaired decision-making capacity.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.