Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Metastatic Pancreatic Adenocarcinoma
• Intervention / Treatment: Drug: Glufosfamide; Drug: Fluorouracil

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Edwin Thomas; Phone Number: 215 554 3530; Email: clinical@eleison-pharma.com

Study Locations

• United States
  • California
    • Whittier, California, United States, 90603
      • Recruiting
      • Innovative Clinical Research Institute
      • Principal Investigator: Richy Agajanian, MD
      • Contact: Kirsten Bettino; Phone Number: 562-652-6532; Email: kbettino@airesearch.us
  • Florida
    • Tampa, Florida, United States, 33612
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Michael Rowland; Phone Number: 813-745-1157; Email: michael.rowland@moffitt.org
      • Principal Investigator: Richard Kim, MD
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gabrail Cancer Center Research
      • Principal Investigator: Nashat Gabrail, MD
      • Contact: Carrie Smith; Phone Number: 330-417-8231; Email: csmith@gabrailcancercenter.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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
• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: glufosfamide; Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle	Drug: Glufosfamide; 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.
Active Comparator: 5-FU; Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week	Drug: Fluorouracil; Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week; Other Names: 5-FU

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	Time from Randomization to death from any cause	Approximately 3-6 months

Collaborators and Investigators

• Sponsor: Eleison Pharmaceuticals LLC.
• Investigators: Study Director: Edwin Thomas, Eleison Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 27, 2013
• First Submitted That Met QC Criteria: September 27, 2013
• First Posted (Estimated): October 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: 5-FU; metastatic pancreatic adenocarcinoma; glufosfamide
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Adenocarcinoma; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Fluorouracil
• Other Study ID Numbers: EP-GF-301