This is a Phase 2 trial in China to evaluate the safety and efficacy of the combination of nab-paclitaxel and gemcitabine administered in patients diagnosed with metastatic pancreatic adenocarcinoma. This study is designed to be a Chinese bridging study to complement the Global pivotal study (CA-046).~The study consists of three parts: (1) Dose evaluation; (2) Single arm to evaluate efficacy following an optimal Simon two-stage design; and (3) Randomized 2-arm to evaluate the efficacy and safety of nab-paclitaxel plus gemcitabine versus gemcitabine alone. These 3 parts will be carried out sequentially. The Part 3 randomized 2-arm portion will only be carried out if deemed necessary per protocol.
The purpose of this study is to determine the safety and efficacy of nab-paclitaxel combined with gemcitabine in Chinese patients with metastatic pancreatic cancer.