Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT01954992

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Led by Eleison Pharmaceuticals LLC. · Updated on 2024-12-31

480

Participants Needed

3

Research Sites

661 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • At least 18 years of age
  • Pancreatic adenocarcinoma confirmed by histology or cytology
  • Metastatic pancreatic cancer
  • Disease progression during or after gemcitabine treatment
  • Measurable or nonmeasurable disease by RECIST criteria
  • Recovered from prior therapy toxicities
  • ECOG performance status 0-1
  • Use of effective contraception from study entry through 6 months post-treatment
  • Ability to understand study and provide informed consent
Not Eligible

You will not qualify if you...

  • More than one prior systemic therapy regimen for metastatic pancreatic cancer
  • Systemic or local antitumor therapy within 14 days before study start
  • Insulin-dependent diabetes mellitus
  • Symptomatic brain metastases
  • Active infection needing antibiotics
  • Known HIV positive or active hepatitis B or C
  • Recent (within 1 year) significant cardiovascular disease
  • Other active malignancies within past year except treated non-melanoma skin or in situ cancer
  • Major surgery within 3 weeks without full recovery
  • Significant lab abnormalities including low hemoglobin, low ANC, low platelets, high bilirubin, elevated liver enzymes, low phosphorus or potassium, high serum creatinine, or low creatinine clearance
  • Pregnancy or breastfeeding
  • Participation in another investigational study within 14 days
  • Medical conditions or medications increasing risk of kidney problems
  • Contraindication or refusal for multiple CT scans
  • Inability or unwillingness to comply with study protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Innovative Clinical Research Institute

Whittier, California, United States, 90603

Actively Recruiting

2

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

3

Gabrail Cancer Center Research

Canton, Ohio, United States, 44718

Actively Recruiting

Loading map...

Research Team

E

Edwin Thomas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer | DecenTrialz