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


Active: Yes
Cancer Type: Pancreatic Cancer NCT ID: NCT07259317
Trial Phases: Phase II Protocol IDs: CORT125134-558 (primary)
Eligibility: , Male and Female Study Type: Treatment
Study Sponsor: Corcept Therapeutics
NCI Full Details: https://clinicaltrials.gov/study/NCT07259317

Summary

This is a Phase 2, single-arm study to evaluate the safety and efficacy of relacorilant in combination with nab-paclitaxel and gemcitabine in patients with previously untreated metastatic pancreatic adenocarcinoma (PDAC).

Objectives

Study treatment will be comprised of relacorilant, combined with nab-paclitaxel and gemcitabine. Each patient will receive relacorilant 150 mg administered orally under fed conditions, once daily for 3 consecutive days on the day before (excluding Cycle 1 Day -1), the day of, and the day after nab-paclitaxel (100 mg/m^2) and gemcitabine (1000 mg/m^2) infusions. Nab-paclitaxel and gemcitabine will be administered on Days 1, 8, and 15 of each 28-day cycle. Patients will receive study treatment until they reach progressive disease (PD), experience unmanageable toxicity, or until other discontinuation criteria are met.
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