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

CStone Pharmaceuticals61 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Gastrointestinal Stromal Tumors

Interventions

AvapritinibDRUG

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 )DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

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.

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.

Data from ClinicalTrials.gov

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