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

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05697107
• Other study ID #: GIST-R-RWD-001
• Status: Active, not recruiting
• Start date: May 20, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: January 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 308
• Est. completion date: December 30, 2023
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Ripretinib Oral Tablet
Oral kinase inhibitor

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (11)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	To assess the efficacy (progression-free survival [PFS]	approximately 7 months
Secondary	DCR	To assess disease control rate (DCR)	approximately 6 months
Secondary	OS	to assess median overall survival (mOS)	approximately 12 months