protocolSection identificationModule nctId: NCT06321055, orgStudyIdInfo id: 22533, briefTitle: An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-20, primaryCompletionDateStruct date: 2024-04-28, completionDateStruct date: 2024-04-28, studyFirstPostDateStruct date: 2024-03-20, lastUpdatePostDateStruct date: 2024-03-20, sponsorCollaboratorsModule leadSponsor name: Bayer, class: INDUSTRY, descriptionModule briefSummary: This is an observational study in which data already collected from people with advanced gastrointestinal stromal tumors are studied.In this observational study data are collected from participants who have private insurance or Medicare and who had started regorafenib treatment.Gastrointestinal stromal tumor (GIST) is a type of cancer that most commonly originates from the stomach or small intestine. Advanced means that the cancer has spread to other parts of the body.The study drug, regorafenib, is already approved for doctors to prescribe to people with GIST. Regorafenib works by blocking certain proteins that cause the growth of cancer cells. Regorafenib is recommended as the third choice of treatment for patients after imatinib and sunitinib have stopped working or have caused side effects that are too severe to continue the treatment. In addition, it is also the recommended first choice of treatment in people with GIST who had low levels of protein called succinate dehydrogenase (SDH) protein. This condition is called SDHdeficient GIST. However, doctors might sometimes give it in a different order. To better understand the treatment patterns with regorafenib for GIST, more knowledge is needed about its use in the real world.The participants in this study had started treatment with regorafenib as part of their regular care from their doctors.The main purpose of this study is to learn more about the use of regorafenib treatment among people with advanced GIST who have private insurance or Medicare in the United States. To do this, researchers will collect information on:Duration of treatment with regorafenib (also known as duration of therapy)The length of time it took for participants to switch to another GIST treatment after starting regorafenib (also known as time to next therapy)The data will come from the participants' information stored in a database, called Merative MarketScan for people in the United States. Data collected will be from April 2002 to September 2023.Researchers will track the data of people with GIST who started regorafenib and will follow them for at least 28 days.In this study, only available data are collected. No visits or tests are required as part of this study., conditionsModule conditions: Advanced Gastrointestinal Stromal Tumor, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: RETROSPECTIVE, enrollmentInfo count: 136, type: ESTIMATED, armsInterventionsModule interventions name: Regorafenib (Stivarga, BAY73-4506), outcomesModule primaryOutcomes measure: Duration of Therapy (DOT) on regorafenib, primaryOutcomes measure: Time to Next Therapy (TTNT) therapy after regorafenib, secondaryOutcomes measure: Number of the guideline-listed medications other than regorafenib, secondaryOutcomes measure: Descriptive analysis of baseline demographic, secondaryOutcomes measure: Descriptive analysis of clinical characteristics, secondaryOutcomes measure: Number of patients with evidence of any metastasis on or after the index date during the follow-up period., secondaryOutcomes measure: Number of patients with evidence of surgery on or after the index date during the follow-up period using Current Procedural Terminology (CPT) codes and International Classification of Disease 9/10 Procedure codes (ICD-PC)., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bayer, city: Whippany, state: New Jersey, zip: 07981, country: United States, geoPoint lat: 40.82454, lon: -74.4171, hasResults: False