An International, Phase 3, Randomized, Multicenter, Open-label Study of Ripretinib vs Sunitinib in Patients with Advanced Gastrointestinal Stromal Tumor (GIST) with KIT Exon 11 and Co-occurring KIT Exons 17 and/or 18 Mutations Who Were Previously Treated with Imatinib (INSIGHT) - DCC-2618-03-003

Deciphera Pharmaceuticals Inc.0 个研究点目标入组 56 人开始时间: 2023年4月26日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Male or female =18 years of age., Histologic diagnosis of GIST with co-occurring KIT exons 11+17/18 mutations confirmed by ctDNA sample analyzed by the central laboratory at pre-screening, Participants must have advanced GIST and radiologic progression on imatinib treatment. Imatinib treatment must have been discontinued at least 10 days prior to the first dose of study drug. All prior imatinib treatment will count as 1 line of therapy (eg, adjuvant imatinib and dose escalation of imatinib)., ECOG PS of =2 at screening., Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotrophin pregnancy test at screening and a negative pregnancy test at Cycle 1 Day 1 prior to the first dose of study drug.

•Presence of co-occurring KIT exons 11+17 and/or 18 mutations that cannot be confirmed by central laboratory testing of ctDNA at pre-screening., History of KIT exon 9 mutation or detection of KIT exons 9, 13, or 14 mutation in a ctDNA sample by the central laboratory at pre-screening., Treatment with any other line of therapy in addition to imatinib for advanced GIST. Imatinib containing combination therapy in the first-line setting is not allowed., A prior or concurrent malignancy whose natural history or treatment have the potential to interfere with the safety or efficacy assessment of this clinical study are not eligible. For example, participants receiving adjuvant cancer treatment are not eligible if those medications are potentially active against GIST or excluded per protocol. NOTE: Participants with a history of breast cancer, requiring continued hormonal treatment (eg, anti-estrogen or an aromatase inhibitor) may continue treatment. Participants with a history of prostate cancer, requiring continued support with luteinizing hormone-releasing hormone agonists, with or without androgens, may continue treatment., Has known active central nervous system metastases.

发起方