[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612879":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":33,"centralContacts":37,"locations":42,"responsibleParty":183,"collaborators":28,"id":185,"slug":28,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":28,"eligibilityCriteria":190,"healthyVolunteers":186,"sex":191,"minAge":192,"maxAge":28,"enrollmentInfo":193,"targetDuration":28,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":45,"whyStopped":28,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":216},{"fullName":5,"class":6},"Corcept Therapeutics","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Relacorilant in Combination with Nab-paclitaxel and Gemcitabine","EXPERIMENTAL","The patient will receive relacorilant administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel and gemcitabine intravenous (IV) infusions. Various dose levels and dosing schedules of relacorilant, nab-paclitaxel, and gemcitabine will be evaluated. On days when relacorilant, nab-paclitaxel, and gemcitabine are administered, relacorilant will be administered first, then nab-paclitaxel, and gemcitabine last.",[13,14,15],"Drug: Relacorilant","Drug: Nab-paclitaxel","Drug: Gemcitabine",[17,24,29],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DRUG","Relacorilant","Relacorilant will be administered as capsules for oral dosing.",[9],[23],"CORT125134",{"type":18,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"Nab-paclitaxel","Nab-paclitaxel will be administered via IV infusion.",[9],null,{"type":18,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Gemcitabine","Gemcitabine will be administered via IV infusion.",[9],[34],{"name":35,"affiliation":5,"role":36},"Sachin Pai","STUDY_DIRECTOR",[38],{"name":5,"role":39,"phone":40,"phoneExt":28,"email":41},"CONTACT","650-684-0171","corceptstudy558@corcept.com",[43,56,66,75,85,95,105,115,124,134,144,153,163,173],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":28},"Site 02","RECRUITING","Scottsdale","Arizona","85258","United States",{"type":51,"coordinates":52},"Point",[53,54],-111.89903,33.50921,{"lat":54,"lon":53},{"facility":57,"status":45,"city":58,"state":59,"zip":60,"country":49,"cosmosGeoPoint":61,"geoPoint":65,"contacts":28},"Site 04","Los Angeles","California","90025",{"type":51,"coordinates":62},[63,64],-118.24368,34.05223,{"lat":64,"lon":63},{"facility":67,"status":45,"city":68,"state":59,"zip":69,"country":49,"cosmosGeoPoint":70,"geoPoint":74,"contacts":28},"Site 12","Orange","92868",{"type":51,"coordinates":71},[72,73],-117.85311,33.78779,{"lat":73,"lon":72},{"facility":76,"status":45,"city":77,"state":78,"zip":79,"country":49,"cosmosGeoPoint":80,"geoPoint":84,"contacts":28},"Site 06","Atlanta","Georgia","30322",{"type":51,"coordinates":81},[82,83],-84.38798,33.749,{"lat":83,"lon":82},{"facility":86,"status":45,"city":87,"state":88,"zip":89,"country":49,"cosmosGeoPoint":90,"geoPoint":94,"contacts":28},"Site 14","Goshen","Indiana","46526",{"type":51,"coordinates":91},[92,93],-85.83444,41.58227,{"lat":93,"lon":92},{"facility":96,"status":45,"city":97,"state":98,"zip":99,"country":49,"cosmosGeoPoint":100,"geoPoint":104,"contacts":28},"Site 03","Grand Rapids","Michigan","49503",{"type":51,"coordinates":101},[102,103],-85.66809,42.96336,{"lat":103,"lon":102},{"facility":106,"status":45,"city":107,"state":108,"zip":109,"country":49,"cosmosGeoPoint":110,"geoPoint":114,"contacts":28},"Site 10","East Brunswick","New Jersey","08816",{"type":51,"coordinates":111},[112,113],-74.41598,40.42788,{"lat":113,"lon":112},{"facility":116,"status":45,"city":117,"state":108,"zip":118,"country":49,"cosmosGeoPoint":119,"geoPoint":123,"contacts":28},"Site 11","Morristown","07960",{"type":51,"coordinates":120},[121,122],-74.48154,40.79677,{"lat":122,"lon":121},{"facility":125,"status":45,"city":126,"state":127,"zip":128,"country":49,"cosmosGeoPoint":129,"geoPoint":133,"contacts":28},"Site 08","Albany","New York","12206",{"type":51,"coordinates":130},[131,132],-73.75623,42.65258,{"lat":132,"lon":131},{"facility":135,"status":136,"city":137,"state":127,"zip":138,"country":49,"cosmosGeoPoint":139,"geoPoint":143,"contacts":28},"Site 05","WITHDRAWN","Lake Success","11042",{"type":51,"coordinates":140},[141,142],-73.71763,40.77066,{"lat":142,"lon":141},{"facility":145,"status":45,"city":146,"state":127,"zip":147,"country":49,"cosmosGeoPoint":148,"geoPoint":152,"contacts":28},"Site 07","Shirley","11967",{"type":51,"coordinates":149},[150,151],-72.8676,40.80149,{"lat":151,"lon":150},{"facility":154,"status":45,"city":155,"state":156,"zip":157,"country":49,"cosmosGeoPoint":158,"geoPoint":162,"contacts":28},"Site 13","Cincinnati","Ohio","45219",{"type":51,"coordinates":159},[160,161],-84.51439,39.12711,{"lat":161,"lon":160},{"facility":164,"status":45,"city":165,"state":166,"zip":167,"country":49,"cosmosGeoPoint":168,"geoPoint":172,"contacts":28},"Site 09","Nashville","Tennessee","37203",{"type":51,"coordinates":169},[170,171],-86.78444,36.16589,{"lat":171,"lon":170},{"facility":174,"status":45,"city":175,"state":176,"zip":177,"country":49,"cosmosGeoPoint":178,"geoPoint":182,"contacts":28},"Site 01","San Antonio","Texas","78229",{"type":51,"coordinates":179},[180,181],-98.49363,29.42412,{"lat":181,"lon":180},{"type":184,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100612879",false,"NCT07259317","Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma","A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naïve Patients With Metastatic Pancreatic Adenocarcinoma (TRIDENT)","Inclusion Criteria:\n\n* Signed and dated informed consent form prior to screening procedures\n* Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC)\n* Initial diagnosis of metastatic disease occurred ≤9 weeks prior to enrollment in the study\n* Life expectancy of ≥3 months\n* Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Able to provide informed consent and comply with protocol requirements\n* Able to swallow and retain oral medication and does not have uncontrolled emesis\n* Has adequate gastrointestinal absorption\n* Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.\n* If a patient received prior treatment of PDAC with chemotherapy, disease progression must have occurred \\>12 months after completing the last dose, and no persistent treatment-related toxicities can be present.\n* Adequate organ function\n* Negative pregnancy test for patients of childbearing potential\n* Agree to use protocol defined precautions to avoid pregnancy\n\nExclusion Criteria:\n\n* Any major surgery within 4 weeks prior to enrollment\n* Prior treatment as follows:\n\n  1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease\n  2. Systemic, inhaled, or prescription strength topical corticosteroids within 5 times the half-life of the corticosteroid used prior to first dose of study drug\n* Received gemcitabine or nab-paclitaxel to treat their PDAC\n* Known germline or somatic breast cancer gene (BRCA) mutation\n* Peripheral neuropathy from any cause \\>Grade 1\n* Medical conditions requiring chronic or frequent treatment with corticosteroids\n* History of severe hypersensitivity or severe reaction to any of study drugs or their excipients\n* Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.\n* Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation\n* Active infection with HIV, hepatitis C or hepatitis B virus\n* Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases\n* History of other malignancy within 3 years prior to enrollment\n* Taking protocol-prohibited medications\n* Concurrent treatment with other investigational treatment studies for cancer\n* Has received a live vaccine within 30 days prior to the study start date","ALL","18 Years",{"count":194,"type":195},80,"ESTIMATED","INTERVENTIONAL",[198],"PHASE2","This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, pharmacokinetics (PK), and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).",[201,202],"Adenocarcinoma","Carcinoma, Pancreatic Ductal",[204,201,205,206],"Pancreatic","PDAC","Pancreas","2026-06-15",{"date":209,"type":210},"2026-06-17","ACTUAL",{"date":212,"type":210},"2026-01-27",{"date":214,"type":195},"2027-09",{"name":5,"class":6},14]