[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advancedmetastatic-cholangiocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advancedmetastatic-cholangiocarcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100659348","phase-2-a-study-to-evaluate-the-efficacy-and-safety-of-pemigatinib-in-participants-with-advancedmetastatic-or-surgically-unresectable-cholangiocarcinoma-with-fgfr2-fusion-or-rearrangements-after-at-least-1-prior-line-of-systemic-therapy-100659348",false,"NCT07862998","A Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced\u002FMetastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy","A Phase 2, Single-Arm, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Advanced\u002FMetastatic or Surgically Unresectable Cholangiocarcinoma With FGFR2 Fusion or Rearrangements After at Least 1 Prior Line of Systemic Therapy (FIGHT-214)","FIGHT-214","Inclusion Criteria:\n\n* Histologically or cytologically confirmed unresectable, locally advanced or metastatic cholangiocarcinoma (CCA).\n* Documented FGFR2 fusion or rearrangement\n* Documented disease progression after at least 1 prior line of systemic chemotherapy, with or without immune checkpoint inhibitors (ICI).\n* Life expectancy ≥ 12 weeks.\n* An ECOG performance status of 0 to 1.\n* Measurable disease by CT or MRI based on RECIST v1.1 as determined by site radiology.\n* Willingness to avoid pregnancy or fathering children.\n\nExclusion Criteria:\n\n* Prior treatment with any FGFR inhibitor for any indication.\n* Liver cirrhosis, Child-Pugh B and C.\n* Known CNS metastases or history of uncontrolled seizures, except participants with treated brain metastases and no evidence of progression for =\\> 4 weeks and on stable or decreasing dose of corticosteroids for management of CNS metastases for =\\>1 week.\n* Current evidence of clinically significant corneal or retinal as confirmed by ophthalmologic examination.\n* History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.\n* History of hypovitaminosis D requiring supraphysiologic doses (eg, 50,000 UI\u002Fweek) to replenish the deficiency.\n* Clinically significant or uncontrolled cardiac disease or history or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful.\n* Use of strong CYP3A4 inhibitors and inducers, moderate CYP3A4 inducers, and concomitant FGFR inhibitor, investigational drug and anticancer medication other than pemigatinib.\n* Women who are pregnant or breastfeeding.\n\nOther protocol-defined inclusion\u002Fexclusion criteria apply.","ALL","18 Years",{"count":20,"type":21},72,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The purpose of this study is to confirm the efficacy and safety of pemigatinib in participants with advanced\u002Fmetastatic or surgically unresectable cholangiocarcinoma with FGFR2 fusion or rearrangements after at least 1 prior line of systemic therapy.",[27,28],"Unresectable Cholangiocarcinoma","Advanced\u002FMetastatic Cholangiocarcinoma",[30,31,32,33],"Cholangiocarcinoma","FGFR inhibitor","FGFR","FGFR rearrangement","NOT_YET_RECRUITING","2026-10-02",{"date":37,"type":38},"2026-10-07","ACTUAL",{"date":40,"type":21},"2026-12-15",{"date":42,"type":21},"2031-03-27",{"name":44,"class":45},"Incyte Corporation","INDUSTRY"]