Study Comparing Ripretinib and Sunitinib for Advanced GIST After Imatinib Treatment

Sponsor: Deciphera Pharmaceuticals, LLC

Sponsor score: 40

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

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

FACILITYZIPCITYSTATE
Mayo Clinic Scottsdale85259ScottsdaleArizona
University of California San Diego Medical Center92103La JollaCalifornia
UCLA Hematology Oncology Center - Main Site90024Los AngelesCalifornia
Stanford Medicine94305StanfordCalifornia
University of Colorado Hospital - Anschutz Cancer Pavillion80045AuroraColorado
Rocky Mountain Cancer Centers80220DenverColorado
Smilow Cancer Hospital at Yale06511New HavenConnecticut
Washington Cancer Institute at MedStar Washington Hospital Center20010Washington D.C.District of Columbia
Mayo Clinic Florida32224JacksonvilleFlorida
Sylvester Comprehensive Cancer Center33136MiamiFlorida

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.