[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641682":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":55,"locations":61,"responsibleParty":157,"collaborators":32,"id":159,"slug":160,"hasResults":161,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":161,"sex":167,"minAge":168,"maxAge":32,"enrollmentInfo":169,"targetDuration":32,"studyType":172,"phases":173,"briefSummary":175,"conditions":176,"keywords":185,"overallStatus":64,"whyStopped":32,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},{"fullName":5,"class":6},"Revolution Medicines, Inc.","INDUSTRY",[8,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: zoldonrasib + chemotherapy","EXPERIMENTAL","study drug in combination with Investigator choice chemotherapy (mFFX or GnP)",[13,14,15,16,17,18,19],"Drug: Zoldonrasib","Drug: Oxaliplatin","Drug: Leucovorin (Calcium Folinate)","Drug: 5-Fluorouracil","Drug: Irinotecan","Drug: Gemcitabine (GEM)","Drug: Nab-paclitaxel",{"label":21,"type":22,"description":23,"interventionNames":24},"Arm B: placebo + chemotherapy","PLACEBO_COMPARATOR","placebo in combination with Investigator choice chemotherapy (mFFX or GnP)",[25,14,15,16,17,18,19],"Drug: Placebo",[27,33,36,40,43,46,49,52],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Zoldonrasib","oral tablets",[9],null,{"type":28,"name":34,"description":30,"armGroupLabels":35,"otherNames":32},"Placebo",[21],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":32},"Oxaliplatin","IV infusion",[9,21],{"type":28,"name":41,"description":38,"armGroupLabels":42,"otherNames":32},"Leucovorin (Calcium Folinate)",[9,21],{"type":28,"name":44,"description":38,"armGroupLabels":45,"otherNames":32},"5-Fluorouracil",[9,21],{"type":28,"name":47,"description":38,"armGroupLabels":48,"otherNames":32},"Irinotecan",[9,21],{"type":28,"name":50,"description":38,"armGroupLabels":51,"otherNames":32},"Gemcitabine (GEM)",[9,21],{"type":28,"name":53,"description":38,"armGroupLabels":54,"otherNames":32},"Nab-paclitaxel",[9,21],[56],{"name":57,"role":58,"phone":59,"phoneExt":32,"email":60},"Revolution Medicines Study Director","CONTACT","1-844-2-REVMED","medinfo@revmed.com",[62,81,96,111,126,141],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"The University of Arizona Cancer Center-North Campus","RECRUITING","Tucson","Arizona","85719","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-110.92648,32.22174,{"lat":74,"lon":73},[77],{"name":78,"role":58,"phone":79,"phoneExt":32,"email":80},"Zimmerman","520-626-8286","priscaz@arizona.edu",{"facility":82,"status":64,"city":83,"state":84,"zip":85,"country":68,"countryCode":69,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Moffitt Cancer Center","Tampa","Florida","33612",{"type":71,"coordinates":87},[88,89],-82.45843,27.94752,{"lat":89,"lon":88},[92],{"name":93,"role":58,"phone":94,"phoneExt":32,"email":95},"Kim","813-745-3691","Cheyenne.Schneider@moffitt.org",{"facility":97,"status":64,"city":98,"state":99,"zip":100,"country":68,"countryCode":69,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Piedmont Healthcare","Atlanta","Georgia","30318",{"type":71,"coordinates":102},[103,104],-84.38798,33.749,{"lat":104,"lon":103},[107],{"name":108,"role":58,"phone":109,"phoneExt":32,"email":110},"Mieri","404-425-1777","Takiyyah.Hamilton@piedmont.org",{"facility":112,"status":64,"city":113,"state":114,"zip":115,"country":68,"countryCode":69,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"University of Chicago Medical Center","Chicago","Illinois","60637",{"type":71,"coordinates":117},[118,119],-87.65005,41.85003,{"lat":119,"lon":118},[122],{"name":123,"role":58,"phone":124,"phoneExt":32,"email":125},"Desgardin","773-834-7188","adesgard@bsd.uchicago.edu",{"facility":127,"status":64,"city":128,"state":129,"zip":130,"country":68,"countryCode":69,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Johns Hopkins University","Baltimore","Maryland","21287",{"type":71,"coordinates":132},[133,134],-76.61219,39.29038,{"lat":134,"lon":133},[137],{"name":138,"role":58,"phone":139,"phoneExt":32,"email":140},"Apostol","410-502-7484","giclinicaltrials@jhmi.edu",{"facility":142,"status":64,"city":143,"state":144,"zip":145,"country":68,"countryCode":69,"cosmosGeoPoint":146,"geoPoint":150,"contacts":151},"Astera Cancer Care","East Brunswick","New Jersey","08816",{"type":71,"coordinates":147},[148,149],-74.41598,40.42788,{"lat":149,"lon":148},[152],{"name":153,"role":58,"phone":154,"phoneExt":155,"email":156},"Yao","732-390-7750","ext 1012","eileen.peng@asterahealthcare.org",{"type":158,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100641682","phase-3-study-of-zoldonrasib--chemo-of-investigators-choice-vs-placebo--chemo-of-investigators-choice-as-first-line-treatment-in-metastatic-kras-g12d-mutated-pancreatic-adenocarcinoma--rasolute-305--100641682",false,"NCT07621718","Study of Zoldonrasib + Chemo of Investigator's Choice vs Placebo + Chemo of Investigator's Choice as First-line Treatment in Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma ( RASolute 305 )","RASolute 305: A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (Modified FOLFIRINOX or Gemcitabine Plus Nab-Paclitaxel) With or Without Zoldonrasib (RMC-9805) as First-line Treatment in Patients With Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma","RASolute 305","Inclusion Criteria:\n\n* At least 18 years old and has provided informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Histologically or cytologically confirmed pancreatic adenocarcinoma.\n* Diagnosis of metastatic disease ≤ 6 weeks prior to screening.\n* Documented KRAS G12D mutation status.\n* Measurable disease per RECIST v1.1.\n* Adequate organ function (bone marrow, liver, kidney, coagulation).\n* Able to take oral medications.\n\nExclusion Criteria:\n\n* Prior treatment with systemic anticancer therapy in unresectable locally advanced or metastatic setting.\n* Prior systemic RAS-targeted therapy any time prior to randomization.\n* Presence of other known driver mutations with approved targeted therapies\n* Active or known history of untreated central nervous system metastatic disease.\n* Any conditions that may affect the ability to take or absorb study drug.\n* Major surgery within 28 days prior to randomization.\n* Patient is unable or unwilling to comply with protocol-required study visits or procedures.","ALL","18 Years",{"count":170,"type":171},670,"ESTIMATED","INTERVENTIONAL",[174],"PHASE3","The purpose of this study is to evaluate the efficacy of an investigational RAS(ON) inhibitor administered in combination with chemotherapy compared to placebo in combination with chemotherapy.",[177,178,179,180,181,182,183,184],"Pancreatic Cancer","Pancreatic Cancer Metastatic","PDAC","PDAC - Pancreatic Ductal Adenocarcinoma","Pancreatic Ductal Adenocarcinoma (PDAC)","Pancreatic Adenocarcinoma Metastatic","Pancreatic Adenocarcinoma","Pancreatic Adenosquamous Carcinoma",[177,179,186,187,188,189,178,182,184,183],"Pancreatic Ductal Adenocarcinoma","RAS","KRAS","RAS Mutation","2026-08-19",{"date":192,"type":193},"2026-08-21","ACTUAL",{"date":195,"type":193},"2026-05-22",{"date":197,"type":171},"2030-04-22",{"name":5,"class":6},6]