Phase Ib Study of Ulixertinib Plus Gemcitabine and Nab-Paclitaxel in Patients with Metastatic Pancreatic Adenocarcinoma.

ABSTRACT:

Background

Ulixertinib is a novel oral ERK inhibitor that has shown promising single-agent activity in a phase I clinical trial that included patients with RAS-mutant cancers.

Methods

We conducted a phase Ib trial combining ulixertinib with gemcitabine and nab-paclitaxel (GnP) for untreated metastatic pancreatic adenocarcinoma. The trial comprised a dose de-escalation part and a cohort expansion part at the recommended phase II dose (RP2D). Primary endpoint was to determine the RP2D of ulixertinib plus GnP and secondary endpoints were to assess toxicity and safety profile, biochemical and radiographic response, progression-free survival (PFS) and overall survival (OS).

Results

Eighteen patients were enrolled. Ulixertinib 600 mg PO twice daily (BID) with GnP was initia

SUBMITTER: Grierson PM 

PROVIDER: S-EPMC9907047 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature