RecruitingPhase 3NCT01954992

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

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


Sponsor

Eleison Pharmaceuticals LLC.

Enrollment

480 participants

Start Date

Apr 1, 2014

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a drug called glufosfamide with the standard chemotherapy drug 5-fluorouracil (5-FU) as a second treatment option for patients with advanced pancreatic cancer whose disease has continued to grow after the first treatment. **You may be eligible if...** - You have been diagnosed with pancreatic cancer that has spread to other parts of the body (metastatic) - You have already received one prior chemotherapy treatment and your cancer continued to grow - You are in reasonably good health and able to carry out daily activities - Your liver, kidney, and blood counts are within acceptable ranges - You are at least 18 years old **You may NOT be eligible if...** - You have received two or more prior chemotherapy regimens for pancreatic cancer - You have serious uncontrolled infections or other serious medical conditions - You are pregnant or breastfeeding - You have significant nerve damage from prior chemotherapy - You have brain metastases (cancer that has spread to the brain) - You have had a prior allergic reaction to similar drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGlufosfamide

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.

DRUGFluorouracil

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

View Full Details on ClinicalTrials.gov

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NCT01954992


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