Phase Ib-II study of ramucirumab combined with nab-paclitaxel and Gemcitabine as first-line treatment in patients with advanced pancreatic adenocarcinoma (RACING).
TL;DR
The trial did not meet its primary endpoint nor did it generate robust evidence of efficacy to warrant further assessment in unselected pancreatic cancer patients.
Abstract
INTRODUCTION The aim of the present clinical trial was to evaluate the efficacy and toxicity of ramucirumab in combination with nab-paclitaxel and gemcitabine as first-line treatment in locally advanced or metastatic pancreatic adenocarcinoma.
Methods
This was a prospective, single-arm, phase Ib-II trial. In phase Ib part of the study, the recommended doses were determined. In phase II part of the study, all patients were treated with the combination at the recommended doses to assess efficacy and toxicity. According to the study primary endpoint, at least 16 patients should respond to the treatment by RECIST criteria. The primary endpoint was overall response rate by RECIST 1.1, defined as best overall response without mandatory confirmation.
Results
From 1/2019 to 10/2021, 53 patients were enrolled. Ten patients (19.2%) had locally advanced disease. The recommended doses determined during phase Ib were Ramucirumab 8mg/Kg Day 1 and 15, Nab-paclitaxel 100mg/m2 day 1,8,15 and gemcitabine 800mg/m2 day 1,8,15 in 28 days cycle. In total, 14 (26.4%) patients responded to treatment (all partial responses). Consequently, the primary endpoint was not met. The median duration of response was 9.9 months (95%CI: 5.4-15 months), median progression-free survival was 4 months (95%CI: 4-10 months) and median overall survival was 14 months (95%CI: 7.3-18 months). Twenty of 52 patients (38%) required a dose reduction and 11 (21%) permanently discontinued study treatment for toxicity.
Conclusions
The trial did not meet its primary endpoint nor did it generate robust evidence of efficacy to warrant further assessment in unselected pancreatic cancer patients CLINICAL TRIALS GOV: NCT03745430.