Advanced Gastrointestinal Stromal TumorNCT06321055
An Observational Study to Learn More About Treatment With Regorafenib in People With Advanced Gastrointestinal Stromal Tumors in the United States
An observational study of Advanced Gastrointestinal Stromal Tumor, run by Bayer at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Gastrointestinal Stromal Tumor
- What is being tested?
- Regorafenib (Stivarga, BAY73-4506)
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult GIST patients with evidence of regorafenib treatment initiation among commercially insured or Medicare patients in the Merative MarketScan database.
Who may be able to join
- Patients will be included if they:
- Have evidence of ≥1 pharmacy claim for regorafenib during the identification period from 1 October 2015, through 30 November 2022 The first prescription claim date for regorafenib during the identification period will be designated as the index date
- Have evidence of ≥1 medical claim with GIST diagnosis codes defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes any time during the baseline period (establish a GIST diagnosis prior to regorafenib initiation- primary analysis)
- Have evidence of ≥1 medical claim with GIST diagnosis codes defined by International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) diagnosis codes any time during the patient identification period (capture all regorafenib patients with GIST diagnosis in the database- sensitivity analysis)
- Have ≥12 months of continuous health plan enrollment prior to the index date, not including the index date
- Have ≥28 days of continuous health plan enrollment after the index date, including the index date
Who cannot join
- Patients will be excluded if they:
- Are aged <18 years as of the index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Regorafenib Use Among Advanced Gastrointestinal Stromal Tumors
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.
Read more
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
- Being tested
- Regorafenib (Stivarga, BAY73-4506)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regorafenib (Stivarga, BAY73-4506)Drug
Retrospective analysis.
| Study group | Role | What they receive |
|---|---|---|
| Advanced Gastro-intestinal soft-tissue tumors (GIST) patients | Adult GIST patients with evidence of regorafenib treatment initiation among commercially insured or Medicare patients in the Merative MarketScan database. Receives: Drug: Regorafenib (Stivarga, BAY73-4506) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Therapy (DOT) on regorafenib
Measured: Retrospective analysis from 1 April 2002 to 30 September 2023
Time to Next Therapy (TTNT) therapy after regorafenib
Measured: Retrospective analysis from 1 April 2002 to 30 September 2023
Secondary outcomes (5)
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)
Measured: Retrospective analysis from 1 April 2002 to 30 September 2023
Descriptive analysis of baseline demographic
Measured: Retrospective analysis from 1 April 2002 to 30 September 2023
Descriptive analysis of clinical characteristics
Measured: 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.
Measured: 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).
Measured: Retrospective analysis from 1 April 2002 to 30 September 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Mar 2024
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastrointestinal Stromal TumorStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321055
- Sponsor's protocol ID
- 22533
- Status last verified
- May 2025
- First submitted
- 14 Mar 2024
- Last updated
- 20 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Regorafenib Use Among Advanced Gastrointestinal Stromal Tumors
- ClinicalTrials.gov ID
- NCT06321055
- Acronym / sponsor ID
- 22533
- Conditions
- Advanced Gastrointestinal Stromal Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Advanced Gastro-intestinal soft-tissue tumors (GIST) patients | – | Drug: Regorafenib (Stivarga, BAY73-4506)Adult GIST patients with evidence of regorafenib treatment initiation among commercially insured or Medicare patients in the Merative MarketScan database. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult GIST patients with evidence of regorafenib treatment initiation among commercially insured or Medicare patients in the Merative MarketScan database.
Key inclusion criteria (6 listed)
- Patients will be included if they:
Key exclusion criteria (2 listed)
- Patients will be excluded if they:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regorafenib (Stivarga, BAY73-4506)Retrospective analysis. | Drug | Advanced Gastro-intestinal soft-tissue tumors (GIST) patients |
Primary outcome
Duration of Therapy (DOT) on regorafenib
Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023
Time to Next Therapy (TTNT) therapy after regorafenib
Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023
5 secondary outcomes
Number of the guideline-listed medications other than regorafenib
Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023
Descriptive analysis of baseline demographic
Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023
Descriptive analysis of clinical characteristics
Time 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.
Time 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).
Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Gastrointestinal Stromal Tumor, run by Bayer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of Therapy (DOT) on regorafenib (time frame: Retrospective analysis from 1 April 2002 to 30 September 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.