About this trial
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).
Eligibility criteria
Qualifiers
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
Disqualifiers
Any major surgery within 4 weeks prior to enrollment
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
Trial design
Treatments tested in this trial
- Relacorilant
- Nab-paclitaxel
- Gemcitabine