Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

A National Multicenter, Noninterventional Clinical Study Evaluating the Safety and Efficacy of Avapritinib in Chinese Patients With Gastrointestinal Stromal Tumor (GIST) in the Real World

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05381753
• Other study ID #: Avapritinib-4-001
• Status: Recruiting
• Start date: August 29, 2022
• Est. completion date: October 2025

Study information

• Verified date: July 2023
• Source: CStone Pharmaceuticals
• Contact: CStone Pharmaceuticals
• Phone: + 86-(0)21-6033-5000
• Email: cstone[@]cstonepharma.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is an observational, multicenter, Real-word study to evaluate the safety and clinical efficacy of avapritinib in Chinese subjects with GIST.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: October 2025
• Est. primary completion date: May 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRa gene exon 18.
• Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRa gene exon 18 and was/will be administrated avapritinib in an neoadjuvant and/or adjuvant setting.
• Cohort 3: Participants must have a confirmed diagnosis of unresectable GIST without mutations in the PDGFRa gene exon 18, KIT gene exon 13, and KIT gene exon 14.

Exclusion Criteria:

• Participants who have participated and may participate in any other interventional clinical trail in the future.
• Participants with any comorbidities not suitable for avapritinib (other TKIs, Cohort 4) treatment assessed by researchers.

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

Drug:
• Avapritinib
Avapritinib will be administered orally at the starting of 300 mg once daily as the label recommended. Investigators can adjust the dosage, frequency, and duration as needed.
• Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )
Investigators will decide which TKI to use as well as the dosage, frequency, and duration.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
CStone Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3		AEs were collected from the start of study drug until 30 days after the last dose, SAEs were collected from the date of the informed consent signature until 30 days after the last dose of study drug, up to 3 years.
Primary	Dose adjustment of avapritinib in cohort 1, 2, and 3		From the start of study drug until 30 days after the last dose, up to 3 years.