[{"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:":41},{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"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":20,"type":21},134,"ESTIMATED","INTERVENTIONAL",[24],"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",[27],"Metastatic Pancreatic Ductal Adenocarcinoma","RECRUITING","2025-02-04",{"date":31,"type":32},"2025-02-06","ACTUAL",{"date":34,"type":32},"2022-05-25",{"date":36,"type":21},"2027-12-31",{"name":38,"class":39},"Belgian Group of Digestive Oncology","OTHER",13,""]