[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gene-rearrangement\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gene-rearrangement":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100495130","phase-2-study-of-futibatinib-in-patients-with-advanced-cholangiocarcinoma-with-fgfr2-fusion-or-rearrangement-100495130",false,"NCT05727176","Study of Futibatinib in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusion or Rearrangement","Phase 2 Study of Futibatinib 20 mg and 16 mg in Patients With Advanced Cholangiocarcinoma With FGFR2 Fusions or Rearrangements","FOENIX-CCA4","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed, locally advanced, metastatic, or unresectable intrahepatic of extrahepatic Cholangiocarcinoma.\n2. Documented evidence of FGFR2 gene fusions or other FGFR2 rearrangement\n3. Received at least one prior systemic gemcitabine and platinum-based regimen for CCA\n4. Documentation of radiographic disease progression on the most recent prior therapy\n5. Measurable disease\n6. performance status 0 or 1\n7. Adequate organ function\n\nExclusion Criteria:\n\n1. History or current evidence of calcium and phosphate homeostasis disorder\n2. Current evidence of clinically significant retinal disorder\n3. Treatment with any of the following within the specified time frame prior to the first dose of futibatinib:\n\n   1. Major surgery within the previous 4 weeks (the surgical incision should be fully healed prior to the first dose of futibatinib) and radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks\n   2. Patients with locoregional therapy, eg, transarterial chemoembolization (TACE), selective internal radiotherapy (SIRT) or ablation within 4 weeks\n   3. Any non investigational anticancer therapy within 3 weeks or have not recovered from side effects of such therapy prior to futibatinib. Endocrine therapy is allowed for patients with breast or prostate cancer\n   4. Targeted therapy or immunotherapy within 3 weeks or within 5 half lives Any investigational agent received within 5 half-lives of the drug or 4 weeks, whichever is shorter.\n   5. Patients with prior FGFR-directed therapy\n4. A serious illness or medical condition(s) including (but not limited to) the following:\n\n   1. Known brain metastasis (not including primary brain tumors) unless patient is clinically stable for ≥1 month\n   2. Known acute systemic infection\n   3. Myocardial infarction, severe\u002Funstable angina, symptomatic congestive heart failure (New York Heart Association \\[NYHA\\] Class III or IV New York Heart Association \\[NYHA\\] Classification) within the previous 2 months; if \\>2 months, cardiac function must be within normal limits and the patient must be free of cardiac-related symptoms\n   4. Significant gastrointestinal disorder(s) that could interfere with the absorption of futibatinib.\n   5. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that in the judgment of the Investigator would make the patient inappropriate for entry into this study.\n5. Known additional malignancy that is progressing or requires active treatment, with the exception of patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or antitumor assessment of the investigational regimen. Exceptions must be discussed with the Sponsor prior to patient enrollment.\n6. Pregnant or lactating female.\n7. Known hypersensitivity or severe reaction to futibatinib or its excipients.","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is an open-label, multinational, randomized Phase 2 study confirming the clinical benefit of 20 mg futibatinib and evaluating the safety and efficacy of 16 mg futibatinib in previously treated CCA harboring FGFR2 gene fusions and other rearrangements.",[27,28,29],"Advanced Cholangiocarcinoma","FGFR2 Fusions","Gene Rearrangement",[31,32,33,34,35,36,37],"Futibatinib","Advanced cholangiocarcinoma","cholangiocarcinoma","FGFR2","Fusion","Rearrangemen","TAS-120","RECRUITING","2026-06-25",{"date":41,"type":42},"2026-06-26","ACTUAL",{"date":44,"type":42},"2023-07-05",{"date":46,"type":21},"2026-12",{"name":48,"class":49},"Taiho Oncology, Inc.","INDUSTRY",65,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100517675","mutational-oncology-in-clinical-practice-100517675","NCT06020625","Mutational Oncology in Clinical Practice","Mutational Oncology in Clinical Practice: Development of a Comprehensive Cancer Genome Profile Pathway.","FPG-500","\\- Patients with neoplasm of the lung, breast, ovary, pancreas, prostate, colorectum, melanoma, GIST, thyroid neoplasm, endometrium, and cholangiocarcinoma:\n\n1. BREAST Locally advanced or metastatic, hormone-responsive, HER2-negative breast neoplasm, progressing after endocrine therapy.\n2. LUNG Metastatic disease.\n3. OVARY Any stage of nonmucinous, non-borderline epithelial carcinoma of the ovary, fallopian tube, or primary peritoneal carcinoma.\n4. PANCREAS Metastatic disease.\n5. PROSTATE Metastatic castration-resistant disease.\n6. COLORECTUM Metastatic disease.\n7. MELANOMA Stage IV or stage III undergoing surgery.\n8. GIST Profiling of c-KIT in case of metastatic disease or for patients undergoing surgery and of PDGFRα for all patients with inoperable or metastatic disease.\n9. THYROID\n10. ENDOMETRIUM\n11. CHOLANGIOCARCINOMA",{"count":60,"type":21},20000,[62],"NA","The study of biological profiling is of fundamental importance in the diagnosis and treatment of many diseases, particularly oncological ones, and for this reason, the integration of molecular characterization into clinical practice becomes essential. NGS allows a high number of samples to be sequenced simultaneously, generating a great deal of genomic information in a short time and at reasonable cost. This information is of fundamental importance for the study of oncogenic drivers and gene alterations that may have a prognostic and\u002For predictive role in response to new molecularly targeted drugs.\n\nPoliclinico A. Gemelli has begun a process of internal reorganization of the research infrastructure following its recognition in 2018 as an Institute of Hospitalization and Treatment with Scientific Character (IRCCS) for its commitment to the disciplines of \"Personalized Medicine\" and \"Innovative Biotechnology.\" In particular, with regard to genomics, will be equipped with a state-of-the-art technological asset that includes a fully automated process for sample preparation and the highest gene sequencing power available today. This condition makes it possible to perform extensive genomic profiling for large numbers of patients at low cost and in reasonable time.",[65,66,29],"Genome Instability","Genetic Predisposition to Disease","2023-08-30",{"date":69,"type":42},"2023-08-31",{"date":71,"type":42},"2022-01-01",{"date":73,"type":21},"2032-01",{"name":75,"class":76},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",1]