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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 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Rapids","Michigan","49503",{"type":52,"coordinates":102},[103,104],-85.66809,42.96336,{"lat":104,"lon":103},{"facility":107,"status":45,"city":108,"state":109,"zip":110,"country":49,"countryCode":50,"cosmosGeoPoint":111,"geoPoint":115,"contacts":28},"Site 10","East Brunswick","New Jersey","08816",{"type":52,"coordinates":112},[113,114],-74.41598,40.42788,{"lat":114,"lon":113},{"facility":117,"status":45,"city":118,"state":109,"zip":119,"country":49,"countryCode":50,"cosmosGeoPoint":120,"geoPoint":124,"contacts":28},"Site 11","Morristown","07960",{"type":52,"coordinates":121},[122,123],-74.48154,40.79677,{"lat":123,"lon":122},{"facility":126,"status":45,"city":127,"state":128,"zip":129,"country":49,"countryCode":50,"cosmosGeoPoint":130,"geoPoint":134,"contacts":28},"Site 08","Albany","New York","12206",{"type":52,"coordinates":131},[132,133],-73.75623,42.65258,{"lat":133,"lon":132},{"facility":136,"status":137,"city":138,"state":128,"zip":139,"country":49,"countryCode":50,"cosmosGeoPoint":140,"geoPoint":144,"contacts":28},"Site 05","WITHDRAWN","Lake Success","11042",{"type":52,"coordinates":141},[142,143],-73.71763,40.77066,{"lat":143,"lon":142},{"facility":146,"status":45,"city":147,"state":128,"zip":148,"country":49,"countryCode":50,"cosmosGeoPoint":149,"geoPoint":153,"contacts":28},"Site 07","Shirley","11967",{"type":52,"coordinates":150},[151,152],-72.8676,40.80149,{"lat":152,"lon":151},{"facility":155,"status":45,"city":156,"state":157,"zip":158,"country":49,"countryCode":50,"cosmosGeoPoint":159,"geoPoint":163,"contacts":28},"Site 13","Cincinnati","Ohio","45219",{"type":52,"coordinates":160},[161,162],-84.51439,39.12711,{"lat":162,"lon":161},{"facility":165,"status":45,"city":166,"state":167,"zip":168,"country":49,"countryCode":50,"cosmosGeoPoint":169,"geoPoint":173,"contacts":28},"Site 09","Nashville","Tennessee","37203",{"type":52,"coordinates":170},[171,172],-86.78444,36.16589,{"lat":172,"lon":171},{"facility":175,"status":45,"city":176,"state":177,"zip":178,"country":49,"countryCode":50,"cosmosGeoPoint":179,"geoPoint":183,"contacts":28},"Site 01","San Antonio","Texas","78229",{"type":52,"coordinates":180},[181,182],-98.49363,29.42412,{"lat":182,"lon":181},{"type":185,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100612879","phase-2-relacorilant-with-nab-paclitaxel-and-gemcitabine-in-patients-with-metastatic-pancreatic-adenocarcinoma-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":196,"type":197},80,"ESTIMATED","INTERVENTIONAL",[200],"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).",[203,204],"Adenocarcinoma","Carcinoma, Pancreatic Ductal",[206,203,207,208],"Pancreatic","PDAC","Pancreas","2026-06-15",{"date":211,"type":212},"2026-06-17","ACTUAL",{"date":214,"type":212},"2026-01-27",{"date":216,"type":197},"2027-09",{"name":5,"class":6},14]