Viewing Study NCT06628739



Ignite Creation Date: 2024-10-26 @ 3:42 PM
Last Modification Date: 2024-10-26 @ 3:42 PM
Study NCT ID: NCT06628739
Status: COMPLETED
Last Update Posted: None
First Post: 2024-05-27

Brief Title: Correlation Between Imatinib Trough Concentration and Efficacy in Advanced GIST Patients with Different Genotypes
Sponsor: None
Organization: None

Study Overview

Official Title: Correlation Between Imatinib Trough Concentration and Efficacy in Advanced Gastrointestinal Stromal Tumors Patients with Different Genotypes
Status: COMPLETED
Status Verified Date: 2024-05
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: No
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Imatinib IM has significantly enhanced the prognosis of patients pts with advanced gastrointestinal stromal tumors GISTs The clinical outcomes may correlate with IM exposure However the efficacy threshold particularly based on different primary KIT mutant remains undefined The objective of this study is to establish the efficacy threshold of imatinib IM plasma trough concentration Cmin at steady-state in Chinese patients with advanced GIST additionally to define subgroup thresholds based on various primary KIT mutations
Detailed Description: Gastrointestinal stromal tumors GISTs are the most common mesenchymal tumors of the gastrointestinal tract The majority of GIST are driven by activating mutuations of KIT 60-70 or platelet-derived growth factor receptor alpha PDGFRA 10-15 in which KIT exon 11 mutation 52-58 and KIT exon 9 mutation 6-9 are the most common types of KIT mutations Patients with different activating KIT mutations have different sensitivity to imatinib therapy In the first-line therapy patients with KIT exon 11 mutation receiving Imatinib with standard dose of 400mgd has the best therapeutic effect Patients with KIT exon 9 mutation have poor sensitivity to the standard dose of imatinib while higher doses can lead to better outcomes The clinical outcomes may correlate with IM exposure However the efficacy threshold of imatinib in Chinese patients with advanced GIST remains unclear The investigators aim to establish the efficacy threshold of imatinib plasma trough concentration Cmin at steady-state in Chinese patients with advanced GIST additionally to define subgroup thresholds based on various primary KIT mutations

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None