[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502384":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":46,"centralContacts":53,"locations":62,"responsibleParty":140,"collaborators":30,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":30,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":30,"enrollmentInfo":151,"targetDuration":30,"studyType":154,"phases":155,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":65,"whyStopped":30,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":171},{"fullName":5,"class":6},"National Cancer Institute, Naples","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard","ACTIVE_COMPARATOR","Nab-paclitaxel 125 mg\u002Fm2 followed by gemcitabine 1000 mg\u002Fm2 on days 1, 8, and 15 (AG); or nab-paclitaxel 150 mg\u002Fm2, followed by gemcitabine 800 mg\u002Fm2, followed by cisplatin 30 mg\u002Fm2 on days 1 and 15, and oral capecitabine 1250 mg\u002Fm2 on days 1-28 (PAXG).",[13,14,15,16],"Drug: Gemcitabine 1000 mg","Drug: Nab paclitaxel","Drug: Cisplatin","Drug: Capecitabine",{"label":18,"type":19,"description":20,"interventionNames":21},"Experimental","EXPERIMENTAL","Chemotherapy (AG or PAXG) + simvastatin oral daily at a fixed dosage of 20 mg in combination with increasing doses of valproic acid administered oral daily from day -7 with an intra-patient titration for a final target serum level of 50-100µg\u002Fml.",[22,23,13,14,15,16],"Drug: Valproic acid","Drug: Simvastatin 20mg",[25,31,34,37,40,43],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Valproic acid","The treatment should be started within 3 days from randomization. One cycle consisted of 28 days of treatment for both arms. Patients will continue to receive study treatment up to 6 cycles until disease progression, unacceptable toxicity, physician's decision, patient's refusal, or any other discontinuation criteria. Continuation of treatment, over the six cycles, will be allowed only in case of clinical benefit, defined as continuous decrease of CA19-9 concentration or radiological response, without unacceptable toxicity.\n\nAll subjects who finish treatment, whichever the reason, will enter in the follow-up. We expect that for the primary endpoint, PFS, follow-up will last up to 10 months after enrollment.\n\nAnyhow, all subjects will be followed until death and data on subsequent treatment will be collected.",[18],null,{"type":26,"name":32,"description":28,"armGroupLabels":33,"otherNames":30},"Simvastatin 20mg",[18],{"type":26,"name":35,"description":28,"armGroupLabels":36,"otherNames":30},"Gemcitabine 1000 mg",[18,9],{"type":26,"name":38,"description":28,"armGroupLabels":39,"otherNames":30},"Nab paclitaxel",[18,9],{"type":26,"name":41,"description":28,"armGroupLabels":42,"otherNames":30},"Cisplatin",[18,9],{"type":26,"name":44,"description":28,"armGroupLabels":45,"otherNames":30},"Capecitabine",[18,9],[47,51],{"name":48,"affiliation":49,"role":50},"Alfredo Budillon","IRCCS I.N.T. \"G. Pascale","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":49,"role":50},"Antonio Avallone",[54,58],{"name":52,"role":55,"phone":56,"phoneExt":30,"email":57},"CONTACT","08117770357","a.avallone@istitutotumori.na.it",{"name":59,"role":55,"phone":60,"phoneExt":30,"email":61},"Alessandra Leone","08117770585","a.leone@istitutotumori.na.it",[63,84,98,111,125],{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":67,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Istituto Nazionale Tumori di Napoli - IRCCS - Fondazione G. Pascale","RECRUITING","Naples","Italy","80131","IT",{"type":71,"coordinates":72},"Point",[73,74],14.26811,40.85216,{"lat":74,"lon":73},[77,80],{"name":78,"role":55,"phone":79,"phoneExt":30,"email":57},"Antonio - Avallone, MD","00390815903629",{"name":81,"role":55,"phone":82,"phoneExt":30,"email":83},"Alfredo - Budillon, MD","00390815903292","a.budillon@istitutotumori.na.it",{"facility":85,"status":65,"city":86,"state":87,"zip":30,"country":67,"countryCode":69,"cosmosGeoPoint":88,"geoPoint":92,"contacts":93},"Università vita e Salute, IRCCS San Raffaele","Milan","Milano",{"type":71,"coordinates":89},[90,91],12.59836,42.78235,{"lat":91,"lon":90},[94],{"name":95,"role":55,"phone":96,"phoneExt":30,"email":97},"Michele Reni","0226437644","reni.michele@hsr.it",{"facility":99,"status":65,"city":100,"state":100,"zip":30,"country":67,"countryCode":69,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Università Cattolica Del Sacro Cuore, IRCCS Fondazione Policlinico Universitario Gemelli - Medical Oncology, Roma, Italia","Roma",{"type":71,"coordinates":102},[103,104],11.10642,44.99364,{"lat":104,"lon":103},[107],{"name":108,"role":55,"phone":109,"phoneExt":30,"email":110},"Giampaolo Tortora","0630157080","giampaolo.tortora@policlinicogemelli.it",{"facility":112,"status":65,"city":113,"state":113,"zip":114,"country":67,"countryCode":69,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"University of Verona Hospital Trust","Verona","37122",{"type":71,"coordinates":116},[117,118],10.9938,45.43854,{"lat":118,"lon":117},[121],{"name":122,"role":55,"phone":123,"phoneExt":30,"email":124},"Michele Milella","0458128502","michele.milella@univr.it",{"facility":126,"status":65,"city":127,"state":127,"zip":30,"country":128,"countryCode":129,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Ramon y Cajal Hospital and Health Research Institute (IRYCIS)","Madrid","Spain","ES",{"type":71,"coordinates":131},[132,133],-3.70256,40.4165,{"lat":133,"lon":132},[136],{"name":137,"role":55,"phone":138,"phoneExt":30,"email":139},"Maria Laura Garcia Bermejo","+34914889706","garciabermejo@gmail.com",{"type":141,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100502384","phase-2-valproic-acidsimvastatin-plus-gemcitabinenab-paclitaxel-based-regimens-in-untreated-metastatic-pancreatic-adenocarcinoma-patients-100502384",false,"NCT05821556","Valproic Acid\u002FSimvastatin Plus Gemcitabine\u002FNab-paclitaxel Based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients","Randomized Phase 2 Study of Valproic Acid combinEd With Simvastatin and Gemcitabine\u002FNab-paclitaxel-based Regimens in Untreated Metastatic Pancreatic Adenocarcinoma Patients (The VESPA Trial).","Inclusion Criteria:\n\n1. Written informed consent to study procedures and to correlative studies.\n2. Histologically or cytologically proven metastatic PDAC.\n3. No prior treatments (chemotherapy, radiation or surgery) for PDAC\n4. Either sex aged ≥ 18 years.\n5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1 at study entry.\n6. Imaging-documented measurable disease, according to RECIST 1.1 criteria.\n7. Known dihydropyrimidine dehydrogenase (DPD) activity is mandatory for patients enrolled in PAXG scheme.\n8. Adequate bone marrow haematological function: absolute neutrophil count (ANC) ≥ 1.5 x 109\u002FL AND platelet count ≥ 100 x 109\u002FL AND haemoglobin ≥ 9 g\u002FdL.\n9. Adequate liver function: total bilirubin ≤ 1.5 x upper limit of normal (ULN) or ≤ 2 in case of biliary stent) and aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 5 X ULN.\n10. Adequate renal function: serum creatinine ≤ 1.5 mg\u002FdL OR creatinine clearance ≥ 60 mL\u002Fmin in males and ≥50 mL\u002Fmin in females (calculated according to Cockroft-Gault formula).\n\nExclusion Criteria:\n\n1. Prior malignancy within one year. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.\n2. Prior chemotherapy or any other medical treatment for metastatic PDAC (previous adjuvant chemotherapy is allowed if terminated \\> 6 months previously).\n3. Patients who have had prior treatment with an HDAC inhibitor and patients who have received compounds with HDAC inhibitor-like activity, such as valproic acid.\n4. Current use of statins or fibrates or any medication for hypercholesterolemia for any time during the 3 months before the study.\n5. Proven hypersensitivity to statins and to any component of the other medications used in the trial.\n6. Major surgical intervention within 4 weeks prior to enrollment;\n7. Pregnancy and breast-feeding.\n8. Brain metastasis.\n9. Hepatitis or any severe liver disorder.\n10. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the investigator's opinion makes it undesirable for the patient to participate in the study, or which would jeopardize compliance with the protocol, or would interfere with the results of the study.\n11. Patients with long QT-syndrome or QTc interval duration \\> 480 msec or concomitant medication with drugs prolonging QTc (see list in the appendix).\n12. History of poor co-operation, non-compliance with medical treatment, unreliability or any condition that may impair the patient's understanding of the Informed consent form.\n13. Participation in any interventional drug or medical device study within 30 days prior to treatment start.\n14. Patients who cannot take oral medication, who require intravenous alimentation, have had prior surgical procedures affecting absorption, or have active peptic ulcer disease.\n15. Sexually active males and females (of childbearing potential) unwilling to practice contraception during the study and until 6 months after the last trial treatment.","ALL","18 Years",{"count":152,"type":153},240,"ESTIMATED","INTERVENTIONAL",[156],"PHASE2","This is a proof-of-concept, Open label, randomized, multicentric, superiority phase-2 study.",[159],"Adenocarcinoma of the Pancreas",[161],"Metastatic","2026-04-09",{"date":164,"type":165},"2026-04-14","ACTUAL",{"date":167,"type":165},"2023-06-12",{"date":169,"type":153},"2027-06",{"name":5,"class":6},5]