Spots Global Cancer Trial Database for Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
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Trial Identification
Brief Title: Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)
Official Title: Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)
Study ID: NCT04046887
Study Description
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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Indiana University Melvin & Bren Simon Cancer Center, Indianapolis, Indiana, United States
Contact Details
Name: Patrick J Loehrer, MD
Affiliation: Indiana University
Role: PRINCIPAL_INVESTIGATOR
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