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Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma

NCT07259317 · Corcept Therapeutics
In plain English

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Official title
A Phase 2, Single-Arm Trial of Relacorilant in Combination With Nab-Paclitaxel and Gemcitabine in Patients With Previously Untreated Metastatic Pancreatic Adenocarcinoma (TRIDENT)
About this study
Study treatment will be comprised of relacorilant, combined with nab-paclitaxel and gemcitabine. Each patient will receive relacorilant 150 mg 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 (100 mg/m\^2) and gemcitabine (1000 mg/m\^2) infusions. Nab-paclitaxel and gemcitabine will be administered on Days 1, 8, and 15 of each 28-day cycle. Patients will receive study treatment until they reach progressive disease (PD), experience unmanageable toxicity, or until other discontinuation criteria are met.
Eligibility criteria
Inclusion Criteria: * Signed and dated informed consent form prior to screening procedures * Histologic diagnosis or cytologic diagnosis of pancreatic adenocarcinoma (PDAC) * Initial diagnosis of metastatic disease occurred ≤6 weeks prior to enrollment in the study * Life expectancy of ≥3 months * Radiographic confirmation of metastatic disease with at least 1 distant tumor metastasis measurable on radiology imaging per RECIST version 1.1 criteria * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Able to provide informed consent and comply with protocol requirements * Able to swallow and retain oral medication and does not have uncontrolled emesis * Has adequate gastrointestinal absorption * Received no prior systemic anticancer therapy to treat metastatic disease * 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. * Adequate organ function * Negative pregnancy test for patients of childbearing potential * Agree to use protocol defined precautions to avoid pregnancy Exclusion Criteria: * Any major surgery within 4 weeks prior to enrollment * Prior treatment as follows: 1. Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease 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 * Received gemcitabine or nab-paclitaxel to treat their PDAC * Known germline or somatic breast cancer gene (BRCA) mutation * Peripheral neuropathy from any cause \>Grade 1 * Medical conditions requiring chronic or frequent treatment with corticosteroids * History of severe hypersensitivity or severe reaction to any of study drugs or their excipients * Concurrent treatment with mifepristone or other glucocorticoid receptor modulators. * Uncontrolled condition(s) which, may confound the results of the trial or interfere with the patient's safety or participation * Active infection with HIV, hepatitis C or hepatitis B virus * Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases * History of other malignancy within 3 years prior to enrollment * Taking protocol-prohibited medications * Concurrent treatment with other investigational treatment studies for cancer * Has received a live vaccine within 30 days prior to the study start date
Study design
Enrollment target: 60 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-01-27
Estimated completion: 2027-07
Last updated: 2026-03-27
Interventions
Drug: Relacorilant 150 mg once daily (QD)Drug: Nab-paclitaxel 100 mg/m^2Drug: Gemcitabine 1000 mg/m^2
Primary outcomes
  • Progression-Free Survival (PFS) (From date of enrollment until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months)
Sponsor
Corcept Therapeutics · industry
Contacts & investigators
ContactCorcept Therapeutics · contact · corceptstudy558@corcept.com · 650-684-0171
InvestigatorSachin Pai · study_director, Corcept Therapeutics
All locations (7)
Site 02Recruiting
Scottsdale, Arizona, United States
Site 04Recruiting
Los Angeles, California, United States
Site 06Recruiting
Atlanta, Georgia, United States
Site 03Recruiting
Grand Rapids, Michigan, United States
Site 05Recruiting
Lake Success, New York, United States
Site 07Recruiting
Shirley, New York, United States
Site 01Recruiting
San Antonio, Texas, United States