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RECRUITING
NCT01954992
PHASE3

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Sponsor: Eleison Pharmaceuticals LLC.

View on ClinicalTrials.gov

Summary

The study is designed to assess whether glufosfamide provides additional survival benefit as compared to bolus 5-FU in patients with metastatic pancreatic cancer who have already progressed or failed therapy on a gemcitabine based first line regimen.

Official title: A Randomized Phase 3 Study of the Efficacy and Safety of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

480

Start Date

2014-04

Completion Date

2026-12

Last Updated

2024-12-31

Healthy Volunteers

No

Interventions

DRUG

Glufosfamide

Glufosfamide: 4500 mg/m2 IV over 6 hours (¼ dose over 30 minutes, ¾ dose over remaining 5.5 hours) on Day 1 of each 21-day cycle.

DRUG

Fluorouracil

Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

Locations (3)

Innovative Clinical Research Institute

Whittier, California, United States

Moffitt Cancer Center

Tampa, Florida, United States

Gabrail Cancer Center Research

Canton, Ohio, United States