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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01954992
- Acronym / sponsor ID
- EP-GF-301
- Conditions
- Metastatic Pancreatic Adenocarcinoma
- Keywords
- glufosfamide, 5-FU, metastatic pancreatic adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Eleison Pharmaceuticals LLC.Industry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 7 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glufosfamide | Experimental | Drug: GlufosfamideGlufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle |
| 5-FU | Active comparator | Drug: FluorouracilFluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlufosfamideGlufosfamide: 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 | glufosfamide |
| FluorouracilAlso: 5-FUFluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week | Drug | 5-FU |
Primary outcome
Overall Survival
Time frame: Approximately 3-6 months
Time from Randomization to death from any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Edwin Thomas study director
Eleison Pharmaceuticals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edwin Thomas (215 554 3530, clinical@eleison-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (time frame: Approximately 3-6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.