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Clinical Trial Summary

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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


NCT number NCT06321055
Study type Observational
Source Bayer
Contact Bayer Clinical Trials Contact
Phone (+)1-888-84 22937
Email clinical-trials-contact@bayer.com
Status Not yet recruiting
Phase
Start date March 20, 2024
Completion date April 28, 2024

See also
  Status Clinical Trial Phase
Completed NCT00254267 - Evaluate the Efficacy of AMG 706 to Treat Advanced Gastrointestinal Stromal Tumors Phase 2
Recruiting NCT04924075 - Belzutifan/MK-6482 for the Treatment of Advanced Pheochromocytoma/Paraganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015) Phase 2