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Completed

NCT Number: NCT06321055

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

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.

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Key information

Conditions

Advanced Gastrointestinal Stromal Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bayer

Whippany, New Jersey, 07981, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Patients will be excluded if they:
  • Are aged <18 years as of the index date

Treatment and study plan

Regorafenib (Stivarga, BAY73-4506)

Drug

Retrospective analysis.

Primary outcomes

  1. Duration of Therapy (DOT) on regorafenib

    Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023

  2. Time to Next Therapy (TTNT) therapy after regorafenib

    Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023

Secondary outcomes

  1. Number of the guideline-listed medications other than regorafenib

    Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023

    • 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)

  2. Descriptive analysis of baseline demographic

    Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023

  3. Descriptive analysis of clinical characteristics

    Time frame: Retrospective analysis from 1 April 2002 to 30 September 2023

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Real-World Regorafenib Use Among Advanced Gastrointestinal Stromal Tumors

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2024
Registry last updated
May 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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