Relacorilant With Nab-Paclitaxel and Gemcitabine in Patients With Metastatic Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCorcept Therapeutics
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
Treatment groups
80 Participants
are divided into 1 treatment groupLocations
14Arizona
Site 0285258, Scottsdale United States
California
Site 0490025, Los Angeles United States
Site 1292868, Orange United States
Georgia
Site 0630322, Atlanta United States
Sponsors and collaborators
Corcept Therapeutics
Lead sponsor
Source ClinicalTrials.gov