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Relacorilant with Chemotherapy for Metastatic Pancreatic Cancer

This study is testing a combination of three drugs: relacorilant, nab-paclitaxel, and gemcitabine, for patients with pancreatic adenocarcinoma (a type of pancreatic cancer) that has spread to other parts of the body (metastatic). The main goals are to see how safe the combination is, what side effects occur, and how well it works to stop the cancer from growing. You might be able to join if you are 18 or older, have metastatic pancreatic adenocarcinoma, and have not had chemotherapy for your metastatic disease. The study is currently enrolling about 80 patients.

Study design
This is a two-part study. The first part will find the best dose of the drugs, and the second part will use that dose to further evaluate safety and effectiveness.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be monitored from the date you join until the cancer progresses or you pass away, for up to 12 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07259317

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Corcept Therapeutics
~80 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:RelacorilantNab-paclitaxelGemcitabine

At a glance

Recruiting sites
15 of 16 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1)
Measured over Up to 28 days after the first dose of study treatment
+2 more outcomes measured

Conditions

Adenocarcinoma
Carcinoma, Pancreatic Ductal

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Pancreatic Adenocarcinoma

NCT07259317

Where you'd take part

This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Site 01

    San Antonio, Texasno site contact published

    Recruiting

  • Site 02

    Scottsdale, Arizonano site contact published

    Recruiting

  • Site 03

    Grand Rapids, Michiganno site contact published

    Recruiting

  • Site 04

    Los Angeles, Californiano site contact published

    Recruiting

  • Site 06

    Atlanta, Georgiano site contact published

    Recruiting

  • Site 07

    Shirley, New Yorkno site contact published

    Recruiting

  • Site 08

    Albany, New Yorkno site contact published

    Recruiting

  • Site 09

    Nashville, Tennesseeno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Adrian Jubb · STUDY_DIRECTOR · Corcept Therapeutics

Who to contact

Corcept Therapeutics
[email protected]
(650) 815-1595
Email the study team

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Eligibility criteria

Inclusion

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

Any major surgery within 4 weeks prior to enrollment
Prior treatment as follows:
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

What this trial measures

  • Percent of Patients who Experience Dose Limiting Toxicity (DLT) (Part 1)Up to 28 days after the first dose of study treatment

    The percentage of patients with a DLT is used to estimate maximum tolerated dose (MTD), the most intense dose/schedule among those evaluated at which \<33% of patients experience DLT.

  • Number of Patients with 1 or More Adverse Events (AEs) Leading to Study Drug Discontinuations or Dose Modifications (Part 1)Time of first dose up to 30 days after last dose
  • Progression-Free Survival (PFS) (Part 2)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

    To evaluate PFS as the time from enrollment until first documented progressive disease (PD) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as determined by the Investigator, or death due to any cause, whichever comes first.