NCT07259317 · Corcept Therapeutics
Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
What this study is about
This is a 2-part, Phase 2 study to evaluate the safety, tolerability, dosing, how the drug moves through the body (PK), and effectiveness of relacorilant in combination with nab-paclitaxel and gemcitabine in chemotherapy-naïve patients with metastatic pancreatic adenocarcinoma (PDAC).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ≤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
Exclusion criteria
- 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
- Scottsdale, Arizona
- Los Angeles, California
- Orange, California
- Atlanta, Georgia
- Goshen, Indiana
- Grand Rapids, Michigan
- East Brunswick, New Jersey
- Morristown, New Jersey
- Albany, New York
- Lake Success, New York
- Shirley, New York
- Cincinnati, Ohio
And 2 more locations — see the full list below.
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 17, 2026 · Source of record for eligibility and locations