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

NCT ID: NCT05381753

Last Updated: 2024-11-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-29
• Study Completion Date: 2024-09-30

Brief Summary

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

Conditions

Gastrointestinal Stromal Tumors

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Ava-mGSIT-P18

Unresectable or metastatic PDGFRA exon 18 GIST

Avapritinib

Intervention Type: DRUG

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.

Ava-Perioperative

Perioperative PDGFRA exon 18 GIST

Avapritinib

Intervention Type: DRUG

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.

Ava-mGIST-other

Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation

Avapritinib

Intervention Type: DRUG

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.

TKI

Unresectable or metastatic PDGFRA exon 18 GIST

Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )

Intervention Type: DRUG

Investigators will decide which TKI to use as well as the dosage, frequency, and duration.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon 18.
• Cohort 2: Participants must have a confirmed diagnosis of GIST with mutations in the PDGFRα 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 PDGFRα 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CStone Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Avapritinib-4-001

Identifier Type: -

Identifier Source: org_study_id