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

Official record

Identifier

NCT07259317

Recruiting locations

country

United States

Interventions studied

RelacorilantNab-paclitaxelGemcitabine

Lead sponsor

Corcept Therapeutics

Target enrolment

80 participants

Study type

INTERVENTIONAL

Phase

Phase 2

Status

Recruiting

First posted

Dec 2, 2025

Last updated on the registry

Sep 25, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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:

  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

Indexed under

Pancreatic Cancer