CompletedNot Applicable

Correlation Between Imatinib Trough Concentration and Efficacy in Advanced GIST Patients with Different Genotypes

China168 participantsStarted 2017-07-01

Plain-language 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.

Who can participate

Age range18 Years – 85 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: * Histologically confirmed metastatic or recurrent GIST * Aged 18 or older * Treated with imatinib as first-line therapy * Had imatinib Cmin measurement at steady state(at least one month after treatment) ≥2 times under long-term maintenance dose of regular medication * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 2 Exclusion Criteria: * Poor appliance * Important treatment data missing * Combined use of CYP enzyme inducers or inhibitors, such as rifampicin, carbamazepine, ketoconazole, ritonavir, rifamequal

What they're measuring

Progression free survival

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06628739

SponsorFirst Affiliated Hospital, Sun Yat-Sen University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Gastrointestinal Stromal Tumor, Malignant trials