check_circleStudy Completed
Advanced gastrointestinal stromal tumor
Bayer Identifier:
22533
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Observational Study to Learn More About Treatment with Regorafenib in People with Advanced Gastrointestinal Stromal Tumors in the United States
Trial purpose
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.
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.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
136Trial Dates
March 2024 - May 2024Phase
N/ACould I Receive a placebo
NoProducts
Stivarga (Regorafenib, BAY73-4506)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Active, not recruiting | Bayer | Whippany, 07981, US |
Primary Outcome
- Duration of Therapy (DOT) on regorafenibdate_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
- Time to Next Therapy (TTNT) therapy after regorafenibdate_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
Secondary Outcome
- Number of the guideline-listed medications other than regorafenib• Imatinib (Gleevec) • Sunitinib (Sutent) • Dasatinib (Sprycel) • Avapritinib (Ayvakit) • Larotrectinib (Vitrakvi) • Entrectinib (Rozlytrek) • Ripretinib (Qinlock) • Dabrafenib (Tafinlar) • Trametinib (Mekinist) • Cabozantinib (Cabometyx) • Nilotinib (Tasigna) • Pazopanib (Votrient) • Sorafenib (Nexavar) • Everolimus in combination with tyrosine kinase inhibitors (Afinitor, Zortress) • Ponatinib (Iclusig) • Binimetinib (Mektovi)date_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
- Descriptive analysis of baseline demographicdate_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
- Descriptive analysis of clinical characteristicsdate_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
- Number of patients with evidence of any metastasis on or after the index date during the follow-up period.date_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
- 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).date_rangeTime Frame:Retrospective analysis from 1 April 2002 to 30 September 2023
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A