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An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States

NCT06321055 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 136

Last updated 2025-05-20

No results posted yet for this study

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.

Conditions

  • Advanced Gastrointestinal Stromal Tumor

Interventions

DRUG

Regorafenib (Stivarga, BAY73-4506)

Retrospective analysis.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06321055 on ClinicalTrials.gov