Observational Study on Avapritinib Treatment in Adults with Metastatic or Unresectable Gastrointestinal Stromal Tumors

What this Trial Is About

Researchers are investigating the real-world treatment patterns and clinical outcomes of Avapritinib in patients with metastatic or unresectable gastrointestinal stromal tumors GIST. GISTs are tumors arising from specialized cells in the gastrointestinal tract, often caused by mutations in KIT or PDGFRA genes. This observational, multicenter study aims to better understand how Avapritinib works for patients with these tumors, especially those with specific PDGFRA mutations resistant to other treatments. Participants in the study are patients with confirmed GIST who are undergoing treatment with Avapritinib. The study observes patients over time without assigning treatments but collects data on their therapy regimens, dosage variations, and any dose adjustments made. The study also monitors the safety of Avapritinib, focusing on side effects such as cognitive effects and intracranial hemorrhage, which have been associated with the drug. Pharmacokinetics and drug exposure levels are also evaluated to optimize dosing. During the study, participants will be followed regularly for assessments including tumor response, clinical benefit, and duration of response over a two-year period. Researchers will collect data on progression-free survival, overall survival, and various safety outcomes. Laboratory tests and pharmacokinetic measurements such as drug concentration and clearance will also be tracked. The study requires patients to provide informed consent and to be willing to comply with follow-up visits and procedures throughout the observation period.

A Multicenter Study of Avapritinib Efficacy and Safety of Metastatic or Unresectable Gastrointestinal Stromal Tumors