[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Belgian Group of Digestive Oncology\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":40},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":10,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"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":19,"type":20},134,"ESTIMATED","INTERVENTIONAL",[23],"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",[26],"Metastatic Pancreatic Ductal Adenocarcinoma","RECRUITING","2025-02-04",{"date":30,"type":31},"2025-02-06","ACTUAL",{"date":33,"type":31},"2022-05-25",{"date":35,"type":20},"2027-12-31",{"name":37,"class":38},"Belgian Group of Digestive Oncology","OTHER",13,""]