Actively Recruiting
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
Eligibility Criteria
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
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
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
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
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