check_circleStudy Completed

Advanced gastrointestinal stromal tumor

Bayer Identifier:

22533

ClinicalTrials.gov Identifier:

NCT06321055

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - Patients will be included if they:
    a) 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
    b) 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)
    c) 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)
    d) Have ≥12 months of continuous health plan enrollment prior to the index date, not including the index date
    e) Have ≥28 days of continuous health plan enrollment after the index date, including the index date
  • - Patients will be excluded if they:
    a) Are aged <18 years as of the index date

Trial summary

Enrollment Goal
136
Trial Dates
March 2024 - May 2024
Phase
N/A
Could I Receive a placebo
No
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Active, not recruiting
Bayer​Whippany, 07981, US

Primary Outcome

  • Duration of Therapy (DOT) on regorafenib
    date_rangeTime Frame:
    Retrospective analysis from 1 April 2002 to 30 September 2023
  • Time to Next Therapy (TTNT) therapy after regorafenib
    date_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 demographic
    date_rangeTime Frame:
    Retrospective analysis from 1 April 2002 to 30 September 2023
  • Descriptive analysis of clinical characteristics
    date_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

Real-World Regorafenib Use Among Advanced Gastrointestinal Stromal Tumors
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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