Actively Recruiting
A Randomized Phase 3 Study of Glufosfamide Compared With Fluorouracil (5-FU) in Patients With Metastatic Pancreatic Adenocarcinoma Previously Treated With Gemcitabine
Led by Eleison Pharmaceuticals LLC. ยท Updated on 2024-12-31
480
Participants Needed
3
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether glufosfamide offers additional survival benefits compared to bolus fluorouracil (5-FU) in patients with metastatic pancreatic adenocarcinoma who have already experienced disease progression after treatment with a gemcitabine-based first-line therapy. This randomized Phase 3 trial is sponsored by Eleison Pharmaceuticals LLC and focuses on patients with advanced pancreatic cancer who have measurable or nonmeasurable disease and have recovered from prior treatment toxicities. Participants are randomly assigned to receive either glufosfamide or fluorouracil. Glufosfamide is given intravenously at a dose of 4500 mg/m2 over 6 hours on Day 1 of each 21-day cycle, while fluorouracil is administered intravenously at 600 mg/m2 over 30 minutes once weekly. These treatments continue throughout the study period as patients are monitored for response and safety. During the trial, participants will undergo regular assessments including imaging scans to measure disease status according to RECIST criteria, laboratory tests, and clinical evaluations to monitor side effects and overall health. The main outcome measured is overall survival, observed over approximately 3 to 6 months. The study also monitors participants' performance status and treatment adherence, with follow-up continuing until study completion or patient withdrawal.
CONDITIONS
Brief 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
- Agreement to use effective contraception if of childbearing potential
- Ability to understand and sign informed consent
You will not qualify if you...
- More than one prior systemic therapy regimen for metastatic pancreatic cancer
- Antitumor therapy within 14 days before starting study treatment
- Insulin-dependent diabetes mellitus
- Symptomatic brain metastases
- Active infection requiring antibiotics
- Known HIV or active hepatitis B or C
- Recent significant cardiovascular disease
- Other active malignancies within the past year (except treated skin or in situ cancers)
- Major surgery within 3 weeks without recovery
- Significant abnormal laboratory test results
- Pregnant or breastfeeding females
- Participation in another investigational drug/device study within 14 days
- Any condition posing unacceptable risk or interfering with study conduct
- Medical history predisposing to renal insufficiency
- Contraindication or unwillingness to undergo multiple CT scans
- Inability or unwillingness to comply with study protocol for any reason
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 to 6 months
Participants receive either Glufosfamide or Fluorouracil as treatment for metastatic pancreatic cancer.
Glufosfamide: 1 infusion visit every 21 days; Fluorouracil: 1 infusion visit weekly
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
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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