Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Recruiting now · Phase 2
Conditions studied: Adenocarcinoma, Carcinoma, Pancreatic Ductal
In brief
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).
Key facts
- Study ID
- NCT07259317
- Run by
- Corcept Therapeutics
- People needed
- 80
- Starts
- 2026-01-27
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 ≤9 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 chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted.
- 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
You may not qualify if…
- Any major surgery within 4 weeks prior to enrollment
- Prior treatment as follows:
- Radiotherapy, surgery, chemotherapy, immunotherapy, investigational therapy for the treatment of metastatic disease
- 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
Where it is running
- Site 01 — San Antonio, Texas, United States (enrolling)
- Site 04 — Los Angeles, California, United States (enrolling)
- Site 12 — Orange, California, United States (enrolling)
- Site 06 — Atlanta, Georgia, United States (enrolling)
- Site 14 — Goshen, Indiana, United States (enrolling)
- Site 15 — Westwood, Kansas, United States (enrolling)
- Site 03 — Grand Rapids, Michigan, United States (enrolling)
- Site 10 — East Brunswick, New Jersey, United States (enrolling)
- Site 11 — Morristown, New Jersey, United States (enrolling)
- Site 08 — Albany, New York, United States (enrolling)
- Site 02 — Scottsdale, Arizona, United States (enrolling)
- Site 07 — Shirley, New York, United States (enrolling)
- Site 13 — Cincinnati, Ohio, United States (enrolling)
- Site 09 — Nashville, Tennessee, United States (enrolling)
- Site 05 — Lake Success, New York, United States
Full record on ClinicalTrials.gov
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