Study on Sunitinib for Treating Cancers with cKIT Genetic Changes
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT06390826
This clinical trial is exploring how well the drug sunitinib works in treating cancers that have specific genetic changes in the cKIT gene. Sunitinib is a type of medication known as a kinase inhibitor, which helps stop or slow down the growth of cancer cells by blocking signals that tell them to multiply.
Patient Parameters
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Program Overview
This study is testing the effectiveness of sunitinib, a medication that targets specific genetic changes in the cKIT gene found in some cancers. By blocking the action of the mutated cKIT, sunitinib aims to stop or slow the spread of cancer cells. The trial involves taking sunitinib daily in cycles, with regular scans and tests to monitor progress. Participants will be followed up regularly after completing the treatment to track their health and any changes in their cancer.
Description
The main goal of this study is to see how many patients experience a reduction in their cancer with sunitinib treatment. Researchers also want to know how long patients live without their cancer getting worse and to identify any markers that might predict how well the treatment works.
Participants will take sunitinib pills once a day for 28 days, followed by a break, in cycles that repeat every 42 days. During the study, patients will have regular scans and heart tests, and provide blood samples and biopsies to help researchers understand the treatment's effects. After finishing the treatment, patients will have follow-up visits every few months for up to three years to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Must meet eligibility criteria from the main MATCH Protocol before joining this study.
- Must have a specific mutation in the cKIT gene, but not in exon 17 or 18.
- Must have normal levels of bilirubin and creatinine, or adequate kidney function.
- Must have normal calcium levels in the blood.
- Must have a recent ECG with no major heart issues.
- If there's a history of heart problems, must have a recent heart function test showing normal results.
- Cannot have serious wounds, recent strokes, heart attacks, or other major health issues in the past year.
- Cannot have had sunitinib before or be taking certain medications that interact with it.
- Cannot have certain types of cancer like gastrointestinal stromal tumor, renal cell carcinoma, or pancreatic neuroendocrine tumor.
- Cannot have uncontrolled high blood pressure or thyroid issues.
- Cannot have had major surgery or significant injuries recently.
- Cannot have brain metastases or require certain blood thinners.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| ECOG-ACRIN Cancer Research Group | 19103 | Philadelphia | Pennsylvania |
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