CompletedNot Applicable

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

China61 participantsStarted 2022-08-29

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence and severity of adverse events(AE) and serious adverse events(SAE)in cohort 1, 2, and 3

Timeframe: 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

Timeframe: From the start of study drug until 30 days after the last dose, up to 3 years.

Trial details

NCT IDNCT05381753

SponsorCStone Pharmaceuticals

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumors trials