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

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Drug: Avapritinib; Drug: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )

• Registration Number: NCT05381753
• Lead Sponsor: CStone Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-09
• Study First Submitted QC: 2022-05-16
• Study First Posted: 2022-05-19
• Study Start: 2022-08-29
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ava-mGSIT-P18	Avapritinib	Unresectable or metastatic PDGFRA exon 18 GIST
Ava-Perioperative	Avapritinib	Perioperative PDGFRA exon 18 GIST
Ava-mGIST-other	Avapritinib	Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation
TKI	Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )	Unresectable or metastatic PDGFRA exon 18 GIST

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China