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

Prior treatment

• 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
• Medical conditions requiring chronic or frequent treatment with corticosteroids
• Concurrent treatment with mifepristone or other glucocorticoid receptor modulators.
• 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

Other illness

• Known germline or somatic breast cancer gene (BRCA) mutation
• History of severe hypersensitivity or severe reaction to any of study drugs or their excipients
• 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
• History of other malignancy within 3 years prior to enrollment

Other

• Peripheral neuropathy from any cause \>Grade 1
• Known untreated parenchymal brain metastasis or uncontrolled central nervous system metastases

• 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