Study Comparing Ripretinib and Sunitinib for Advanced GIST After Imatinib Treatment
Sponsor: Deciphera Pharmaceuticals, LLC
ClinicalTrials ID:NCT03673501
This clinical trial is testing two different medications, ripretinib and sunitinib, to see which is more effective for patients with advanced gastrointestinal stromal tumors (GIST) who have not responded to or cannot tolerate the first-line treatment, imatinib.
Patient Parameters
| Parameter | Options |
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Program Overview
This study involves two groups of patients with advanced GIST who have either not responded to or cannot tolerate imatinib, a common first treatment. Participants will be randomly assigned to receive either ripretinib or sunitinib. The study aims to compare the effectiveness of these two drugs in controlling the cancer. About 426 patients will participate, with each group receiving their assigned medication in cycles over six weeks.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Have a confirmed diagnosis of GIST and provide a tumor sample.
- Must have a report confirming the genetic makeup of the tumor. If not available, a new sample may be needed.
- Must have not responded to or cannot tolerate imatinib.
- Be in relatively good health with an ECOG score of 0 to 2.
- Women of childbearing age must have a negative pregnancy test before starting the study.
- Must agree to use effective birth control during the study.
- Must have at least one tumor that can be measured by scans.
- Have good organ function and blood cell counts.
- Any side effects from previous treatments must be mild or resolved.
- Must understand the study and agree to participate by signing a consent form.
- Cannot participate in other clinical trials while in this study, except for observational studies.
Exclusion Criteria
- Have received other treatments for advanced GIST besides imatinib.
- Have another cancer that could affect the study results.
- Have active cancer spread to the brain.
- Have serious heart conditions or recent heart attack.
- Have a heart pumping ability below 50%.
- Have had recent blood clots or bleeding issues.
- Have a prolonged QT interval on an ECG.
- Have had major surgery recently.
- Have significant other health issues.
- Have active infections like HIV or hepatitis.
- Are pregnant or breastfeeding.
- Have allergies to the study drugs.
- Have digestive issues that prevent taking oral medication.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Scottsdale | 85259 | Scottsdale | Arizona |
| University of California San Diego Medical Center | 92103 | La Jolla | California |
| UCLA Hematology Oncology Center - Main Site | 90024 | Los Angeles | California |
| Stanford Medicine | 94305 | Stanford | California |
| University of Colorado Hospital - Anschutz Cancer Pavillion | 80045 | Aurora | Colorado |
| Rocky Mountain Cancer Centers | 80220 | Denver | Colorado |
| Smilow Cancer Hospital at Yale | 06511 | New Haven | Connecticut |
| Washington Cancer Institute at MedStar Washington Hospital Center | 20010 | Washington D.C. | District of Columbia |
| Mayo Clinic Florida | 32224 | Jacksonville | Florida |
| Sylvester Comprehensive Cancer Center | 33136 | Miami | Florida |
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