A new phase 2, interventional, open-label, single-group assignment study of 5 years of adjuvant imatinib treatment in patients with gastrointestinal stromal tumors (GISTs) is expected to open on July 1, 2022.
The aim is to assess the safety and efficacy of 5 years of adjuvant imatinib treatment in patients with large tumors (10 cm or greater) and a mitotic index of 10/50HPFs or higher, or those with tumor rupture according to the Nishida classification.
During the trial, an estimated 35 participants will be administered oral imatinib mesylate at a dose of 400 mg once daily, the standard approved dose for the treatment, for 3 years. This will be followed by 2 years of intraperitoneal treatment. The primary outcome measure is progression-free survival, defined as the period of time from the first dose of imatinib to the date of progression or death due to any cause.
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Participants are eligible who are aged 20 years or older with histologically confirmed GISTs with CD117(+), DOG-1(+), or mutations in KIT or PDGFRα genes, and with completely resected localized GISTs within 12 weeks prior to the start of adjuvant imatinib, according to the modified National Institutes of Health criteria. The trial site has the full eligibility criteria.
The trial is not yet recruiting participants. It is expected to start on July 1, 2022, and run through to April 30, 2030. It is sponsored by the Asan Medical Center in Seoul, South Korea.
Imatinib is a protein tyrosine kinase inhibitor with antineoplastic activity. It is used to treat certain types of cancers, including GIST, acute lymphoblastic leukemia, chronic myeloid leukemia, and myelodysplastic/myeloproliferative diseases.
Imatinib inhibits adenosine triphosphate binding and prevents phosphorylation and subsequent cell proliferation by binding to an intracellular pocket inside tyrosine kinases. It was approved by the US Food and Drug Administration on February 1, 2002.
5 years of adjuvant imatinib in patients with gastrointestinal stromal tumor with a high risk. US National Library of Medicine. Updated May 23, 2022. Accessed May 24, 2022.