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A Phase II, Single-Arm Trial of Relacorilant in Combination with Nab-Paclitaxel and Gemcitabine in Chemotherapy-Naive Patients with Metastatic Pancreatic Adenocarcinoma

Cancer
Farshid Dayyani
Pancreas

Study Description

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).

Eligibility

-Patients are at least 18 years of age at the time of consent

-Confirmed histologic or cytologic diagnosis of pancreatic adenocarcinoma (PDAC) (note: mixed histologies,

other histologies, neuroendocrine, acinar, and ampullary cancers are not eligible).

  • Received no prior systemic anticancer chemotherapy to treat metastatic PDAC. Treatment of PDAC with a single agent RAS inhibitor is permitted if the last dose of the RAS inhibitor was taken no more than 8 weeks prior to C1D1 on this study.

-Has had major surgery, other than diagnostic surgery within 4 weeks prior to study enrollment.

-Received gemcitabine or nab-paclitaxel to treat their PDAC

-Has received a live vaccine within 30 days prior to the study start date

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