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Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

NCT01954992 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2024-12-31

No results posted yet for this study

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.

Conditions

  • Metastatic Pancreatic Adenocarcinoma

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

Sponsors & Collaborators

  • Eleison Pharmaceuticals LLC.

    lead INDUSTRY

Principal Investigators

  • Edwin Thomas · Eleison Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01954992 on ClinicalTrials.gov