[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475540":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":53,"locations":59,"responsibleParty":236,"collaborators":238,"id":241,"slug":242,"hasResults":243,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":243,"sex":249,"minAge":250,"maxAge":47,"enrollmentInfo":251,"targetDuration":47,"studyType":254,"phases":255,"briefSummary":257,"conditions":258,"keywords":47,"overallStatus":62,"whyStopped":47,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":269},{"fullName":5,"class":6},"Belgian Group of Digestive Oncology","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A NALIRI","ACTIVE_COMPARATOR","Cycle length: 14 days\n\nDay 1:\n\n* Leucovorin: 400 mg\u002Fm² IV - Dilute in 250 mL DSW and administer over two hours\n* Liposomal irinotecan (FBE): 70 mg\u002Fm² IV\\* - Dilute in 500 mL DSW and administer over 90 min\n* 5 FU: 2400 mg\u002Fm² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg\u002FmL) or the total dose diluted in 100 to 150 mL NS.\n\n  * Patients who are known to be homozygous for UGT1A1\\*28 should start treatment with 50 mg\u002Fm2 ONIVYDE. If they do not encounter drug related toxicities during the first cycle of therapy (started at a reduced dose of 50 mg\u002Fm2), they may have the dose of ONIVYDE increased to a dose of 70 mg\u002Fm2 in subsequent cycles based on individual patient tolerance.",[13,14,15],"Drug: Nanoliposomal irinotecan","Drug: 5 FU","Drug: Leucovorin",{"label":17,"type":18,"description":19,"interventionNames":20},"Arm B NALIRINOX","EXPERIMENTAL","Cycle length: 14 days\n\nDay 1:\n\n* Oxaliplatin 60 mg IV - Dilute in 500 mL D5W and administer over two hours (prior to leucovorin). Shorter oxaliplatin administration schedules (eg. 1mg\u002Fm2 per minute) appear to be safe.\n* Leucovorin: 400 mg\u002Fm² IV - Dilute in 250 mL DSW and administer over two hours (after oxaliplatin)\n* Nanoliposomal irinotecan (FBE): 50 mg\u002Fm² IV - Dilute in 500 mL D5W and administer over 90 min\n* 5 FU: 2400 mg\u002Fm² IV - Dilute in 500 to 1000 mL 0,9% NS of DSW and administer as a continuous IV infusion over 46 hours. To accommodate an ambulatory pump for outpatient treatment can be administered undiluted (50 mg\u002FmL) or the total dose diluted in 100 to 150 mL NS.",[13,14,15,21],"Drug: Oxaliplatin",[23,30,36,43],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Nanoliposomal irinotecan","In the control arm (Naliri) a dose of 70mg\u002Fm² is administered in combination with 5FU and leucovorin In the investigational arm (Nalirinox) a dose of 50mg\u002Fm² is administered in combination with 5FU, leucovorin and oxaliplatin",[9,17],[29],"Onyvide",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"5 FU","In the control arm (Naliri) a dose of 2400 mg\u002Fm² is administered in combination with nanoliposomal irinotecan and leucovorin In the investigational arm (Nalirinox) a dose of 2400 mg\u002Fm² is administered in combination with nanoliposomal irinotecan, leucovorin and oxaliplatin",[9,17],[35],"Fluorouracil",{"type":24,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"Leucovorin","In the control arm (Naliri) a dose of 400 mg\u002Fm² is administered in combination with nanoliposomal irinotecan and 5FU In the investigational arm (Nalirinox) a dose of 400 mg\u002Fm² is administered in combination with nanoliposomal irinotecan, 5FU and oxaliplatin",[9,17],[41,42],"Folinate","Elvorine",{"type":24,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Oxaliplatin","Only administered in the investigational arm (Nalirinox): a dose of 60 mg\u002Fm² is administered in combination with nanoliposomal irinotecan, 5FU and Leucovorin",[17],null,[49],{"name":50,"affiliation":51,"role":52},"Ivan Borbath","University hospital St-luc, Brussel","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":47,"email":58},"Lina Dewever","CONTACT","+32 (0) 479 36 63 82","lina.dewever@bgdo.org",[60,78,93,104,118,133,146,159,172,182,196,209,222],{"facility":61,"status":62,"city":63,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"UZ Antwerpen","RECRUITING","Antwerp","2650","Belgium","BE",{"type":68,"coordinates":69},"Point",[70,71],4.40026,51.22047,{"lat":71,"lon":70},[74,76],{"name":75,"role":56,"phone":47,"phoneExt":47,"email":47},"Sanne Wouters",{"name":77,"role":52,"phone":47,"phoneExt":47,"email":47},"Timon Vandamme, Prof",{"facility":79,"status":62,"city":80,"state":81,"zip":82,"country":65,"countryCode":66,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"ULB Erasme","Brussels","Brussels Capital","1070",{"type":68,"coordinates":84},[85,86],4.34878,50.85045,{"lat":86,"lon":85},[89,91],{"name":90,"role":56,"phone":47,"phoneExt":47,"email":47},"Axelle Ghilain",{"name":92,"role":52,"phone":47,"phoneExt":47,"email":47},"Jean-Luc Van Laethem, Dr",{"facility":94,"status":62,"city":80,"state":81,"zip":95,"country":65,"countryCode":66,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"Cliniques Universitaires Saint-Luc UCL","1200",{"type":68,"coordinates":97},[85,86],{"lat":86,"lon":85},[100,102],{"name":101,"role":56,"phone":47,"phoneExt":47,"email":47},"Tuan Le",{"name":103,"role":52,"phone":47,"phoneExt":47,"email":47},"Ivan Borbath, Prof",{"facility":105,"status":62,"city":106,"state":106,"zip":107,"country":65,"countryCode":66,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"CHC MontLégia","Liège","4000",{"type":68,"coordinates":109},[110,111],5.56749,50.63373,{"lat":111,"lon":110},[114,116],{"name":115,"role":56,"phone":47,"phoneExt":47,"email":47},"Jocelyne Gilson",{"name":117,"role":52,"phone":47,"phoneExt":47,"email":47},"Ghislain Houbiers, Dr",{"facility":119,"status":120,"city":121,"state":122,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":123,"geoPoint":127,"contacts":128},"AZ St-Lucas","NOT_YET_RECRUITING","Bruges","West-Vlaanderen",{"type":68,"coordinates":124},[125,126],3.22424,51.20892,{"lat":126,"lon":125},[129,131],{"name":130,"role":56,"phone":47,"phoneExt":47,"email":47},"Tania Maerten",{"name":132,"role":52,"phone":47,"phoneExt":47,"email":47},"Liesbeth Holvoet, Dr",{"facility":134,"status":62,"city":135,"state":47,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"AZ Imelda","Bonheiden",{"type":68,"coordinates":137},[138,139],4.54714,51.02261,{"lat":139,"lon":138},[142,144],{"name":143,"role":56,"phone":47,"phoneExt":47,"email":47},"Doreen Iwens",{"name":145,"role":52,"phone":47,"phoneExt":47,"email":47},"Pieter-Jan Cuyle, Dr.",{"facility":147,"status":62,"city":148,"state":47,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":149,"geoPoint":153,"contacts":154},"Grand Hopital de Charleroi","Charleroi",{"type":68,"coordinates":150},[151,152],4.44448,50.41136,{"lat":152,"lon":151},[155,157],{"name":156,"role":56,"phone":47,"phoneExt":47,"email":47},"Matthias Papier",{"name":158,"role":52,"phone":47,"phoneExt":47,"email":47},"Javier Carrasco, Dr.",{"facility":160,"status":62,"city":161,"state":47,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"AZ Maria Middelares","Ghent",{"type":68,"coordinates":163},[164,165],3.71667,51.05,{"lat":165,"lon":164},[168,170],{"name":169,"role":56,"phone":47,"phoneExt":47,"email":47},"Margaux Vansteelant",{"name":171,"role":52,"phone":47,"phoneExt":47,"email":47},"Els Monsaert, Dr.",{"facility":173,"status":62,"city":161,"state":47,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":174,"geoPoint":176,"contacts":177},"University Hospital Ghent",{"type":68,"coordinates":175},[164,165],{"lat":165,"lon":164},[178,180],{"name":179,"role":56,"phone":47,"phoneExt":47,"email":47},"Tine Derre",{"name":181,"role":52,"phone":47,"phoneExt":47,"email":47},"Karen Geboes, Prof.",{"facility":183,"status":62,"city":184,"state":47,"zip":185,"country":65,"countryCode":66,"cosmosGeoPoint":186,"geoPoint":190,"contacts":191},"Pôle Hospitalier Jolimont (HELORA)","Haine-Saint-Paul","7100",{"type":68,"coordinates":187},[188,189],4.1885,50.45544,{"lat":189,"lon":188},[192],{"name":193,"role":56,"phone":194,"phoneExt":47,"email":195},"Isabelle Buelens","064\u002F234662","Isabelle.Buelens@helora.be",{"facility":197,"status":62,"city":198,"state":47,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"CHU Ambroise Paré","Mons",{"type":68,"coordinates":200},[201,202],3.95229,50.45413,{"lat":202,"lon":201},[205,207],{"name":206,"role":56,"phone":47,"phoneExt":47,"email":47},"Mariane Blockmans",{"name":208,"role":52,"phone":47,"phoneExt":47,"email":47},"Marie Diaz, Dr.",{"facility":210,"status":62,"city":211,"state":47,"zip":47,"country":65,"countryCode":66,"cosmosGeoPoint":212,"geoPoint":216,"contacts":217},"CHR Namur","Namur",{"type":68,"coordinates":213},[214,215],4.86746,50.4669,{"lat":215,"lon":214},[218,220],{"name":219,"role":56,"phone":47,"phoneExt":47,"email":47},"Christine Leon",{"name":221,"role":52,"phone":47,"phoneExt":47,"email":47},"Yeter Gokburun, Dr.",{"facility":223,"status":62,"city":224,"state":47,"zip":225,"country":65,"countryCode":66,"cosmosGeoPoint":226,"geoPoint":230,"contacts":231},"AZ Turnhout","Turnhout","2300",{"type":68,"coordinates":227},[228,229],4.94471,51.32254,{"lat":229,"lon":228},[232],{"name":233,"role":56,"phone":234,"phoneExt":47,"email":235},"Nel Bovin","0032 14406912","nel.bovin@azturnhout.be",{"type":237,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR",[239],{"name":240,"class":6},"University Hospital St Luc, Brussels","100475540","phase-2-a-study-evaluating-the-efficacy-of-5-fu--naliri-and-5-fu--nalirinox-for-pdac-nalpac-100475540",false,"NCT05472259","A Study Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for PDAC (NALPAC)","A Non-comparative Randomized Phase 2 Study, Evaluating the Efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC), Progressive After Gemcitabine-Abraxane or Gemcitabine Monotherapy","NALPAC","Inclusion Criteria:\n\n* Histologically proven metastatic adenocarcinoma of the pancreas\n* Progression documented after gemcitabine-Abraxane, or gemcitabine monotherapy\n* Signed written informed consent\n* Age ≥ 18\n* ECOG PS 0\u002F1 at study entry\n* Measurable disease\n* Adequate renal (serum creatinine ≤ 1.5x upper reference range), liver (total bilirubin ≤ 1.5x upper reference range) and hematopoietic functions (PMN ≥ 1,5x109\u002FL, platelets ≥ 100x109\u002FL, hemoglobin ≥ 9g\u002Fdl)\n* INR\u002FPTT ≤ 1.5x ULN\n* Life expectancy of at least 12 weeks\n* Effective contraception for both male and female patients if the risk of conception exists during treatment and for one month after the last administration\n* Peripheral Neuropathy \\\u003C grade 2\n\nExclusion Criteria:\n\n* Uncontrolled concurrent CNS, cardiac, infectious diseases, hypertension\n* History of myocardial infarction, deep venous or arterial thrombosis, CVA during the last 6 months\n* Known hypersensitivity to any of the components, including excipients, of study treatments\n* Previous malignancy in the last past 3 years except basal cell cancer of the skin or preinvasive cancer of the cervix or carcinoma in situ of any type\n* Pregnancy or breast feeding\n* Medical or psychological conditions that would not permit the patient to complete the study or sign inform consent\n* Unstable angina, congestive heart failure ≥NYHA class II\n* Uncontrolled hypertension despite optimal management (systolic blood pressure \\>150 mmHg or diastolic pressure \\> 90mmHg)\n* HIV infection\n* Complete DPD deficiency\n* Liver failure, cirrhosis Child Pugh B or C\n* Active chronic hepatitis B or C with a need for antiviral treatment\n* Brain metastasis\n* Major surgery, open biopsy or significant traumatic injury within 4 weeks prior to the first dose of treatment\n* History of organ allograft\n* Ongoing uncontrolled, serious infection\n* Renal failure requiring dialysis\n* Patients receiving or having received any investigational treatment within 4 weeks prior to study entry, or participating to another clinical study","ALL","18 Years",{"count":252,"type":253},134,"ESTIMATED","INTERVENTIONAL",[256],"PHASE2","A non-comparative randomized phase 2 study, evaluating the efficacy of 5-FU + NALIRI and 5-FU + NALIRINOX for metastatic pancreatic ductal adenocarcinoma (PDAC), progressive after Gemcitabine-Abraxane or Gemcitabine monotherapy",[259],"Metastatic Pancreatic Ductal Adenocarcinoma","2025-02-04",{"date":262,"type":263},"2025-02-06","ACTUAL",{"date":265,"type":263},"2022-05-25",{"date":267,"type":253},"2027-12-31",{"name":5,"class":6},13]