A phase II study to evaluate LY2603618 in combination with gemcitabine in pancreatic cancer patients.

ABSTRACT:

Background

The aim of this study was to determine whether checkpoint kinase 1 inihibitor (CHK1), LY2603618, and gemcitabine prolong overall survival (OS) compared to gemcitabine alone in patients with unresectable pancreatic cancer.

Methods

Patients with Stage II-IV locally advanced or metastatic pancreatic cancer were randomized (2:1) to either 230 mg of LY2603618/1000 mg/m² gemcitabine combined or 1000 mg/m² gemcitabine alone. OS was assessed using both a Bayesian augment control model and traditional frequentist analysis for inference. Progression-free survival (PFS), overall response rate (ORR), duration of response, pharmacokinetics (PK), and safety (Common Terminology Criteria for Adverse Events [AEs] v 3.0) were also evaluated.

Results

Nin

SUBMITTER: Laquente B 

PROVIDER: S-EPMC5312529 | biostudies-literature | 2017 Feb

REPOSITORIES: biostudies-literature