[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659348":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":26,"studyPopulation":26,"armGroups":33,"interventions":39,"overallOfficials":46,"centralContacts":50,"locations":26,"responsibleParty":60,"collaborators":26,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":26,"enrollmentInfo":72,"targetDuration":26,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":87,"whyStopped":26,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":26},{"fullName":5,"class":6},"Incyte Corporation","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Objective Response","Defined as having a confirmed best response of complete response (CR) or partial response (PR), as determined by an independent central review (ICR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.","Up to approximately 18 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Duration of Response (DoR)","Determined from earliest date of CR or PR until the earliest date of progressive disease (PD) as determined by an ICR per RECIST v1.1 or death due to any cause.",{"measure":18,"description":19,"timeFrame":12},"Progression-free survival (PFS)","Determined from start of therapy until the earliest date of PD as determined by an ICR per RECIST v1.1 or death due to any cause.",{"measure":21,"description":22,"timeFrame":12},"Overall Survival (OS)","Determined from the start of therapy until death due to any cause.",{"measure":24,"description":25,"timeFrame":12},"Number of treatment-emergent adverse events","Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug until up to 30 days after the last dose of study drug.",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE",[34],{"label":35,"type":36,"description":26,"interventionNames":37},"Pemigatinib","EXPERIMENTAL",[38],"Drug: Pemigatinib",[40],{"type":41,"name":35,"description":42,"armGroupLabels":43,"otherNames":44},"DRUG","Pemigatinib at the protocol-defined dose administered orally once daily in 21-day cycles with 14 days on therapy followed by 7 days off therapy.",[35],[45],"Pemazyre",[47],{"name":48,"affiliation":5,"role":49},"Incyte Medical Monitor","STUDY_DIRECTOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":26,"email":55},"Incyte Corporation Call Center (US)","CONTACT","1.855.463.3463","medinfo@incyte.com",{"name":57,"role":53,"phone":58,"phoneExt":26,"email":59},"Incyte Corporation Call Center (ex-US)","+800 00027423","eumedinfo@incyte.com",{"type":61,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","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":73,"type":74},72,"ESTIMATED","INTERVENTIONAL",[77],"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.",[80,81],"Unresectable Cholangiocarcinoma","Advanced\u002FMetastatic Cholangiocarcinoma",[83,84,85,86],"Cholangiocarcinoma","FGFR inhibitor","FGFR","FGFR rearrangement","NOT_YET_RECRUITING","2026-10-02",{"date":90,"type":91},"2026-10-07","ACTUAL",{"date":93,"type":74},"2026-12-15",{"date":95,"type":74},"2031-03-27",{"name":5,"class":6}]