Ripretinib in Chinese Patients With Advanced GIST: a Real World Study

January 15, 2023 updated by: Shen Lin, Peking University

A Large Scale, Multicenter, Real-World Study on Patients With Advanced GIST Receiving Ripretinib

to evaluate the clinical efficacy, safety and predictive factors of ripetinib in Chinese patients with advanced GIST in the real world

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Ripretinib has become the standard ≥ 4L treatment in advanced GIST. Given the small sample size of patients in the China bridging study of INVICTUS as well as the short marketing time of ripretinib, further exploration on the long-term efficacy and safety of ripretinib, as well as the dominant gene mutation type of ripretinib in Chinese GIST patients is required. Hence, we plan to further explore the efficacy of ripretinib, predictors of efficacy, etc. by collecting and analyzing real-world data from Chinese patients with advanced GIST recieving ripretinib.

Study Type

Observational

Enrollment (Actual)

308

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100142
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Histologically confirmed gastrointestinal stromal tumor

Description

Inclusion Criteria:

-≥18 years old

  • Histologically confirmed gastrointestinal stromal tumor (GIST)
  • At least one measurable lesion (mRECIST v1.1)
  • Received or receiving ripretinib treatment

Exclusion Criteria:

  • Patients who received <1 cycle of ripretinib treatment
  • Medical records are incomplete

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: approximately 7 months
To assess the efficacy (progression-free survival [PFS]
approximately 7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DCR
Time Frame: approximately 6 months
To assess disease control rate (DCR)
approximately 6 months
OS
Time Frame: approximately 12 months
to assess median overall survival (mOS)
approximately 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University

Collaborators

The First Affiliated Hospital with Nanjing Medical University
Xiangya Hospital of Central South University
Sun Yat-sen University
Fudan University
First Affiliated Hospital, Sun Yat-Sen University
RenJi Hospital
First Affiliated Hospital of Zhejiang University
Wuhan Union Hospital, China
Fujian Medical University Union Hospital
First Affiliated Hospital of Chongqing Medical University

Investigators

  • Principal Investigator: Lin Shen, MD, Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

August 30, 2022

Study Completion (Anticipated)

December 30, 2023

Study Registration Dates

First Submitted

January 15, 2023

First Submitted That Met QC Criteria

January 15, 2023

First Posted (Estimate)

January 24, 2023

Study Record Updates

Last Update Posted (Estimate)

January 24, 2023

Last Update Submitted That Met QC Criteria

January 15, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIST-R-RWD-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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