[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"CEBIOTEX\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591929","phase-2-ceb-01-in-paediatrics-with-locally-resectable-abdominal-tumours-100591929",false,"NCT06986811","CEB-01 in Paediatrics With Locally Resectable Abdominal Tumours","First-in-paediatrics, Open Label, Exploratory, Externally Controlled Clinical Trial to Evaluate Safety, Efficacy and Pharmacokinetics of 7-ethyl-10-hydroxy Camptothecin (SN-38) Formulated as a Biocompatible Polymeric Nanofiber Membrane (CEB-01) for Treatment, in Addition to Standard of Care, of Paediatric Patients From Birth to Less Than 18 Years of Age With a Locally Resectable Tumours in Comparison to Standard of Care","CEB-01-RLP01-C","Inclusion Criteria:\n\nTo be eligible to participate in this trial, an individual must meet all the following criteria:\n\n1. ≤ 18 years.\n2. Participants must have a diagnosis of:\n\n   1. De novo or recurrent abdominal soft-tissue sarcoma.\n   2. De novo or recurrent high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification, regardless of response to frontline therapy, diagnosed either by a former histologic verification of neuroblastoma and\u002For former demonstration of tumour cells in the bone marrow with increased urinary catecholamines at the time of study enrolment. Participants who were initially considered low or intermediate risk but were then reclassified as high risk are also eligible.\n   3. Other tumours: recurrent Wilms tumour, de novo or recurrent Germ cell tumour, de novo or recurrent extracranial malignant rhabdoid tumour, de novo or recurrent synovial sarcoma, de novo or recurrent fibrolamellar hepatocellular carcinoma, and de novo or recurrent desmoplastic small round cell tumour.\n3. A histology assessment is required for enrolment of de novo cases. A new histology assessment is not required for enrolment of the recurrent cases, but it will be obtained from the resected tumour to assess whether the histology is identical to the original tumour.\n4. Participants previously treated with irinotecan will be eligible if they have not had documented progressive disease during treatment.\n5. Participants might have more than one surgically removable lesion.\n6. Adequate liver, renal, haematological, and cardiac function.\n7. Participants must have fully recovered from the acute toxic effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial.\n8. Landky or Karnosfsky functional performance status score ≥ 50 at screening.\n9. Female participants of childbearing potential must have a negative urine betahuman chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.\n10. Female and male participants of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.\n11. Life expectancy greater than 6 months.\n12. The participant legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.\n\nExclusion Criteria\n\nAn individual who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Metastatic lesions.\n2. Other malignancies within past 2 years except for in-situ cancers or basal\u002Fsquamous cell skin cancer. Subjects with other malignancies are eligible if they are disease-free for at least 24 months or have a clinically stable concurrent malignancy not requiring tumour-directed treatment.\n3. Active bacterial, viral or fungal infection.\n4. Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.\n5. Impossibility of ensuring adequate follow-up.\n6. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n7. Contraindication to computed tomography (CT) scan.\n8. Major surgery within 14 days prior to the implant of study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery.\n9. Other relevant concomitant illnesses.\n10. Participant' status post-allogeneic stem cell transplant are not eligible.\n11. Participants with disease of any major organ system that would compromise their ability to withstand therapy.\n12. Patients with tumour size requiring CEB-01 implant that exceeds the maximum implantable surface area based on Body Surface Area (BSA) correction.\n13. Patients with known hypersensitivity to SN-38 or any of the CEB-01 excipients.\n14. Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.","ALL","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the abdominal cancer tumor, CEB-01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of abdominal tumors after surgery, while keeping a tolerable toxicity profile.\n\nThe study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in pediatric patients with locally resectable abdominal tumors including Soft Tissue Sarcoma (STS), high-risk Neuroblastoma (NB), Wilms tumour (WT), germ cell tumors (GCT), extracranial malignant rhabdoid tumour (eMRT), synovial sarcoma (SS), desmoplastic small round cell tumour (DSRCT) and fibrolamellar hepatocellular carcinoma (FL-HCC",[27],"Locally Resectable Paediatric Tumours",[29,30,31],"CEB-01","SN-38","Locally resectable paediatrics tumours","RECRUITING","2025-05-28",{"date":35,"type":36},"2025-05-31","ACTUAL",{"date":38,"type":36},"2025-05-06",{"date":40,"type":21},"2029-05",{"name":42,"class":43},"CEBIOTEX","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100557495","phase-2-ceb-01-in-locally-resectable-pancreatic-cancer-100557495","NCT06538857","CEB-01 in Locally Resectable Pancreatic Cancer","Exploratory Clinical Trial to Assess Safety, Tolerability Efficacy and Pharmacokinetics of CEB-01 PLGA Membrane in Participants With Pancreatic Cancer.","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Participants must have a diagnosis of:\n\n   1. Lesion\u002Fs of histologically or cytologically confirmed de novo carcinoma, adenocarcinoma or ductal adenocarcinoma of the pancreas with only locally advanced disease, resectable or borderline resectable.\n   2. Histopathological confirmation of the diagnosis can be done during surgery by means of intraoperative biopsy as per clinical practice.\n\n   No need of preoperative biopsy.\n3. Participants previously treated with chemotherapy will be eligible if they have not had documented progressive disease during treatment.\n4. Participants must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion obtained by a validate imaging technique (i.e., magnetic resonance imaging (MRI), computed tomography (CT) scan, PET scan, ultrasounds or others) that can be accurately measured.\n5. Participants should have surgically removable lesion\u002Fs for what they will be submitted to a pancreatoduodenectomy.\n6. Normal renal function as defined by biochemical parameters as follows: creatinine ≤2 mg\u002Fdl or creatinine clearance ≥ 60 ml\u002Fmin\u002F1.73 m2.\n7. Haematological and cardiac function as defined by biochemical and haematological parameters as follows: haemoglobin (Hb) ≥10 g\u002FdL (with preoperative transfusion), platelets ≥80.000\u002Fmm3 with intraoperative transfusion, white blood cells (WBC) ≥3.000\u002Fmm3, neutrophil count ≥1.500\u002Fmm3.\n8. Liver function as defined by biochemical parameters as follows: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 4 times the upper limit of normality \\[ULN\\]. Recommended serum bilirubin for eligibility is bilirubin ≤ 10 mg\u002Fdl (or equivalent value in μmol\u002FL units). Preoperative biliary drainage to be done according to regular practice in each center. Patients in whom preoperative biliary drainage cannot be performed or biliary drainage was not completely effective, individualized decision to be made when bilirubin is ≥ 10 mg\u002Fdl (or equivalent value in μmol\u002FL units).\n9. Participants must have fully recovered from the acute toxic effects (Grade 3 or above) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this trial.\n10. Neoadjuvant chemotherapy is allowed in borderline and\u002For locally advanced cases borderline completed at least 4 weeks before surgery.\n11. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.\n12. Female subjects of childbearing potential must have a negative urine beta-human chorionic gonadotropin (beta-hCG) pregnancy test at time of screening.\n13. Men and women of childbearing potential must be willing to use adequate contraception throughout the study and for 6 months after surgery.\n14. The participant or a legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained prior to any protocol screening procedures.\n\nExclusion Criteria:\n\n1. Other malignancies within past 2 years.\n2. R2 resections (macroscopic disease remains after surgery).\n3. Patients with homozygous UGT1A1 known to be at risk of increased toxicity with irinotecan and SN-38.\n4. Active bacterial, viral or fungal infection.\n5. Known history of active human immunodeficiency virus (HIV) infection, hepatitis B, hepatitis C or chronic liver disease. Testing is not required in the absence of clinical findings or suspicion.\n6. Impossibility of ensuring adequate follow-up.\n7. Participants who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.\n8. Contraindication to computed tomography scan (CT).\n9. Major surgery within 14 days prior to starting study drug or still in recovery after experiencing surgical complications; neither tumour biopsy nor central line insertion are considered a major surgery.\n10. Other relevant concomitant illnesses.\n11. Participants' status post-allogeneic stem cell transplant are not eligible.\n12. Participants with disease of any major organ system that would compromise their ability to withstand therapy.\n13. Pregnancy or lactation. Pregnant women are excluded from this study; if the patient is a lactating mother, breastfeeding should be discontinued.",{"count":53,"type":21},39,[24],"The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent. After surgical removal of the pancreatic cancer tumor, CEB 01 will be placed in the surgical bed for a local and sustained release of the chemotherapy. This is expected to delay or prevent local recurrence of pancreatic cancer after surgery, while keeping a tolerable toxicity profile.\n\nThe study aims to assess the safety, tolerability, pharmacokinetics, and efficacy of CEB-01 in patients with locally resectable pancreatic cancer",[57],"Pancreatic Carcinoma",[59,60,61],"Locally advanced disease","Resectable pancreatic cancer","Borderline resectable pancreatic cancer","2025-05-20",{"date":64,"type":36},"2025-05-23",{"date":66,"type":36},"2024-08-20",{"date":68,"type":21},"2028-09",{"name":42,"class":43},4,""]