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
Overview
- Phase
- Not Applicable
- Intervention
- Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )
- Conditions
- Gastrointestinal Stromal Tumors
- Sponsor
- CStone Pharmaceuticals
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Dose adjustment of avapritinib in cohort 1, 2, and 3
- Status
- Completed
- Last Updated
- 2 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Cohort 1 and 4: Participants must have a confirmed diagnosis of unresectable GIST with mutations in the PDGFRα gene exon
- •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.
Arms & Interventions
TKI
Unresectable or metastatic PDGFRA exon 18 GIST
Intervention: Tyrosine kinase inhibitors other than avapritinib ( imatinib, sunitinib, et al )
Ava-mGSIT-P18
Unresectable or metastatic PDGFRA exon 18 GIST
Intervention: Avapritinib
Ava-Perioperative
Perioperative PDGFRA exon 18 GIST
Intervention: Avapritinib
Ava-mGIST-other
Unresectable or metastatic GIST without KIT exon 13，14，or PDGFRA exon 18 mutation
Intervention: Avapritinib
Outcomes
Primary Outcomes
Dose adjustment of avapritinib in cohort 1, 2, and 3
Time Frame: 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
Time Frame: 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.