[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593833":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":33,"locations":39,"responsibleParty":177,"collaborators":179,"id":183,"slug":27,"hasResults":184,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":184,"sex":190,"minAge":191,"maxAge":27,"enrollmentInfo":192,"targetDuration":27,"studyType":195,"phases":196,"briefSummary":198,"conditions":199,"keywords":204,"overallStatus":42,"whyStopped":27,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"SCRI Development Innovations, LLC","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Fruquinitinib + FOLFIRI","EXPERIMENTAL","Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.",[13,14],"Drug: fruquintinib","Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","fruquintinib","Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.",[9],[22],"Fruzaqla",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)","Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg\u002Fm2 intravenous infusion (IV), leucovorin 400 mg\u002Fm2 (or 200 mg\u002Fm2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg\u002Fm2 bolus injection and 5-FU continuous IV infusion of 2400 mg\u002Fm2 over 46 to 48 hours. The 5-FU Bolus may be omitted starting from Cycle 1 Day 1 at the investigators discretion, specifically in participants with a history of cytopenias or toxicities within the first line of treatment.",[9],null,[29],{"name":30,"affiliation":31,"role":32},"Meredith Pelster, MD","SCRI Oncology Partners","STUDY_CHAIR",[34],{"name":35,"role":36,"phone":37,"phoneExt":27,"email":38},"Sarah Cannon Sarah Cannon Development Innovations, LLC","CONTACT","844-710-6157","SCRI.InnovationsMedical@scri.com",[40,53,63,73,83,92,102,111,121,130,140,149,158,168],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":27},"Rocky Mountain Cancer Center - Primary","RECRUITING","Denver","Colorado","80218","United States",{"type":48,"coordinates":49},"Point",[50,51],-104.9847,39.73915,{"lat":51,"lon":50},{"facility":54,"status":42,"city":55,"state":56,"zip":57,"country":46,"cosmosGeoPoint":58,"geoPoint":62,"contacts":27},"Illinois Cancer Specialists","Arlington Heights","Illinois","60005",{"type":48,"coordinates":59},[60,61],-87.98063,42.08836,{"lat":61,"lon":60},{"facility":64,"status":42,"city":65,"state":66,"zip":67,"country":46,"cosmosGeoPoint":68,"geoPoint":72,"contacts":27},"Maryland Oncology Hematology","Columbia","Maryland","21044",{"type":48,"coordinates":69},[70,71],-76.83942,39.24038,{"lat":71,"lon":70},{"facility":74,"status":42,"city":75,"state":76,"zip":77,"country":46,"cosmosGeoPoint":78,"geoPoint":82,"contacts":27},"Minnesota Oncology Hematology - Primary","Maple Grove","Minnesota","55369",{"type":48,"coordinates":79},[80,81],-93.45579,45.07246,{"lat":81,"lon":80},{"facility":84,"status":42,"city":65,"state":85,"zip":86,"country":46,"cosmosGeoPoint":87,"geoPoint":91,"contacts":27},"Missouri Cancer Associates","Missouri","65201",{"type":48,"coordinates":88},[89,90],-92.33407,38.95171,{"lat":90,"lon":89},{"facility":93,"status":42,"city":94,"state":95,"zip":96,"country":46,"cosmosGeoPoint":97,"geoPoint":101,"contacts":27},"Oncology Associates of Oregon - Primary","Eugene","Oregon","97401",{"type":48,"coordinates":98},[99,100],-123.08675,44.05207,{"lat":100,"lon":99},{"facility":103,"status":42,"city":104,"state":95,"zip":105,"country":46,"cosmosGeoPoint":106,"geoPoint":110,"contacts":27},"Northwest Cancer Specialists - Compass","Portland","97213",{"type":48,"coordinates":107},[108,109],-122.67621,45.52345,{"lat":109,"lon":108},{"facility":112,"status":42,"city":113,"state":114,"zip":115,"country":46,"cosmosGeoPoint":116,"geoPoint":120,"contacts":27},"Alliance Cancer Specialists","Wynnewood","Pennsylvania","19096",{"type":48,"coordinates":117},[118,119],-75.27074,40.00289,{"lat":119,"lon":118},{"facility":31,"status":42,"city":122,"state":123,"zip":124,"country":46,"cosmosGeoPoint":125,"geoPoint":129,"contacts":27},"Nashville","Tennessee","37203",{"type":48,"coordinates":126},[127,128],-86.78444,36.16589,{"lat":128,"lon":127},{"facility":131,"status":42,"city":132,"state":133,"zip":134,"country":46,"cosmosGeoPoint":135,"geoPoint":139,"contacts":27},"Texas Oncology - Central\u002FSouth Texas","Austin","Texas","78705",{"type":48,"coordinates":136},[137,138],-97.74306,30.26715,{"lat":138,"lon":137},{"facility":141,"status":42,"city":142,"state":133,"zip":143,"country":46,"cosmosGeoPoint":144,"geoPoint":148,"contacts":27},"Texas Oncology - Gulf Coast","Beaumont","77702",{"type":48,"coordinates":145},[146,147],-94.10185,30.08605,{"lat":147,"lon":146},{"facility":150,"status":42,"city":151,"state":133,"zip":152,"country":46,"cosmosGeoPoint":153,"geoPoint":157,"contacts":27},"Texas Oncology - Northeast Texas","Tyler","75702",{"type":48,"coordinates":154},[155,156],-95.30106,32.35126,{"lat":156,"lon":155},{"facility":159,"status":42,"city":160,"state":161,"zip":162,"country":46,"cosmosGeoPoint":163,"geoPoint":167,"contacts":27},"Virginia Oncology Associates","Norfolk","Virginia","23502",{"type":48,"coordinates":164},[165,166],-76.28522,36.84681,{"lat":166,"lon":165},{"facility":169,"status":42,"city":170,"state":161,"zip":171,"country":46,"cosmosGeoPoint":172,"geoPoint":176,"contacts":27},"Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)","Salem","24153",{"type":48,"coordinates":173},[174,175],-80.05476,37.29347,{"lat":175,"lon":174},{"type":178,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR",[180],{"name":181,"class":182},"Takeda Development Center Americas, Inc.","INDUSTRY","100593833",false,"NCT07011576","A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","A Phase II Study Investigating Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (FRUITFUL)","FRUITFUL","Key Inclusion Criteria:\n\n* Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.\n* Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600\n* Participants must have received first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX\u002FBEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.\n* At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2\n\nKey Exclusion Criteria:\n\n* Current treatment with other anticancer treatments within 21 days of the first dose of study treatment\n* Major surgery within 4 weeks of the first planned dose of study treatment\n* More than one prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.\n* Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.\n* Uncontrolled, symptomatic brain metastases\n* Uncontrolled, symptomatic gastrointestinal disease\n* Participants with uncontrolled hypertension\n* Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy\n* Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy\n* Documented major electrocardiogram (ECG) abnormalities which are clinically significant.\n* Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment\n* Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening","ALL","18 Years",{"count":193,"type":194},60,"ESTIMATED","INTERVENTIONAL",[197],"PHASE2","This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:\n\n* Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting\n* Evaluate the safety of the combination of fruquintinib + FOLFIRI",[200,201,202,203],"Colon Cancer","Rectal Cancer","Colorectal Cancer","Colorectal Cancer (CRC)",[205,200,206,207,208,209,210,211,212,213],"Colorectal cancer","Rectal cancer","Metastatic colorectal cancer","mCRC","VEGFR inhibitor","Fruquintinib","FOLFIRI","Second line","2L mCRC","2026-06-10",{"date":216,"type":217},"2026-06-12","ACTUAL",{"date":219,"type":217},"2025-09-29",{"date":221,"type":194},"2027-06",{"name":5,"class":6},14]