Conditions: Pancreatic Neoplasms
Keywords: Pancreatic cancer Metastatic pancreatic cancer treatment for pancreatic cancer Abraxane clinical research trials Celgene clinical research trials
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 83
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: nab-paclitaxel at 125 mg/m\^2, intravenous (IV) infusion over 30 to 40 minutes followed by gemcitabine at 1000 mg/ m\^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).

Interventions: intervention 1: nab-paclitaxel intervention 2: Gemcitabine
Intervention descriptions: intervention 1: nab-paclitaxel at 125 mg/m\^2, by IV infusion over 30 to 40 minutes (maximum infusion time not to exceed 40 minutes) intervention 2: Gemcitabine at 1000 mg/m\^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).

Protocol document: