Metastatic Pancreatic AdenocarcinomaPhase 3NCT01954992
Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
A Phase 3 study testing Glufosfamide and Fluorouracil in people with Metastatic Pancreatic Adenocarcinoma, run by Eleison Pharmaceuticals LLC. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Adenocarcinoma
- What is being tested?
- Glufosfamide and Fluorouracil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2014to Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age
- Pancreatic adenocarcinoma proven either by histology (surgical biopsy) or cytology (CT- or endoscopic-guided)
- Metastatic pancreatic cancer
- Disease progression during or after treatment with gemcitabine (alone or in combination with other agents; at regular, not radiosensitizing, doses)
- Measurable or nonmeasurable disease by RECIST criteria (at least one target or nontarget lesion)
- Recovered from reversible toxicities of prior therapy
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- ECOG performance status 0-1
- All women of childbearing potential and all men must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) from entry into the study through 6 months after the last dose of chemotherapy
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
Who cannot join
- More than one prior systemic therapy regimen for metastatic pancreatic cancer (radiosensitizing doses of 5-FU or gemcitabine at the time of initial radiotherapy do not count as a prior systemic therapy regimen)
- Hormonal therapy, radiation therapy, biologic therapy, chemotherapy or other systemic antitumor therapy for pancreatic cancer within 14 days prior to Cycle 1 Day 1
- Insulin-dependent diabetes mellitus (patients with type 2 diabetes controlled with oral glucose lowering agents and the occasional use of insulin are permitted in the study)
- Symptomatic brain metastases (baseline CT scan is not required in asymptomatic patients)
- Active clinically significant infection requiring antibiotics
- Known HIV positive or active hepatitis B or C
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- Recent (one year) history or symptoms of cardiovascular disease (NYHA Class 2, 3, or 4), particularly coronary artery disease, arrhythmias or conduction defects with risk of cardiovascular instability, uncontrolled hypertension, clinically significant pericardial effusion, or congestive heart failure
- No other active malignancies (other than treated non-melanoma skin cancer or treated in situ cancer) within the past year
- Major surgery within 3 weeks of the start of study treatment, without complete recovery
- Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including electrolytes, and urinalysis)
- Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain)
- ANC <1500/μL
- Platelet count <100,000/μL
- Total bilirubin > 1.5×ULN
- AST/ALT > 2.5-fold above ULN (>5-fold above ULN if liver metastases)
- Phosphorus < LLN
- Potassium < LLN
- Serum creatinine > 2 mg/dL
- Creatinine clearance < 60 mL/min (calculated by Cockcroft-Gault formula)
- Females who are pregnant or breast-feeding
- Participation in an investigational drug or device study within 14 days of the first day of dosing on this study
- Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the patient in this study
- Any medical history, concurrent disease or concomitant medication which could reasonably predispose the patient to renal insufficiency while on study treatment
- Contraindication or unwillingness to undergo multiple CT scans
- Unwillingness or inability to comply with the study protocol for any other reason
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Gabrail Cancer Center Research
Canton, Ohio, 44718
Carrie Smith, 330-417-8231, csmith@gabrailcancercenter.com
Nashat Gabrail, MD
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Michael Rowland, (813) 745-1157, michael.rowland@moffitt.org
Richard Kim, MD
- Recruiting
Innovative Clinical Research Institute
Whittier, California, 90603
Kirsten Bettino, 562-652-6532, kbettino@airesearch.us
Richy Agajanian, MD
About this study
Official title: 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
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
- Being tested
- Glufosfamide, Fluorouracil
- Keywords
- glufosfamide, 5-FU, metastatic pancreatic adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlufosfamideDrug
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.
FluorouracilDrug
Also called 5-FU
Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
| Study group | Role | What they receive |
|---|---|---|
| glufosfamide | Experimental | Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle Receives: Drug: Glufosfamide |
| 5-FU | Active comparator | Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week Receives: Drug: Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival
Time from Randomization to death from any cause
Measured: Approximately 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startApr 2014
- Primary completionMar 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eleison Pharmaceuticals LLC.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin Thomas, Study director, Eleison Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954992
- Sponsor's protocol ID
- EP-GF-301
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2013
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes