Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
brief summary
The purpose of this study is to determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel in Pancreatic ductal adenocarcinoma (PDAC)
detailed description
This is a single-institution, prospective, phase I dose escalation trial of lonsurf combined with gemcitabine and nab-paclitaxel using the 3+3 design. This study will enroll 18 patients over 12-15 months.
Primary Objective To determine the recommended phase 2 dose (RP2D) of the combination of lonsurf, gemcitabine and nab-paclitaxel
Secondary Objectives
1. Examine safety and toxicity of the combination 2. Estimate response rate to the combination 3. Estimate median overall survival (mOS) of the treated population 4. Estimate median progression free survival (mPFS) of the treated population 5. Estimate disease control rate (DCR) at 8 weeks 6. Evaluate quality of life while receiving the combination therapy
official title
Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)