NCT04046887

Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced (PDAC)

Phase I Study of Lonsurf in Combination With Gemcitabine and Nab-Paclitaxel in Patients With Advanced Pancreatic Ductal Adenocarcinoma (PDAC)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Patrick Joseph Loehrer Sr. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pancreatic Cancer
• Pancreatic Ductal Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Lonsurf	Lonsurf will be administered orally twice a day on days 2-6 and 16-20 of every 28-day cycle at a dose of 25 mg/m2, 20 mg/m2 or 30 mg/m2 depending on cohort assignment.
DRUG	Gemcitabine	Gemcitabine will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 800 mg/m2, 600 mg/m2 or 1000 mg/m2 depending on cohort assignment.
DRUG	Nab-Paclitaxel	Nab-Paclitaxel will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 100 mg/m2, 75 mg/m2 or 125 mg/m2 depending on cohort assignment.

Timeline

• Start date: 2019-09-11
• Primary completion: 2021-05-10
• Completion: 2023-10-04
• First posted: 2019-08-06
• Last updated: 2024-01-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study