Recruiting

Phase 3

Glufosfamide vs. 5-FUGlufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Sponsor:

Eleison Pharmaceuticals LLC.

Code:

NCT01954992

Conditions

Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Glufosfamide

Fluorouracil

Study Details

Brief 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.

Conditions

Metastatic Pancreatic Adenocarcinoma

Study ID

NCT01954992

Start date

Apr, 2014

Status verified date

Dec, 2024

Completion date

Dec, 2026

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

480 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: glufosfamide

Glufosfamide: 4500 mg/m2 IV over 6 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

Interventions

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.

Fluorouracil

Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week

Primary outcome measure

Overall Survival [ Time Frame: Approximately 3-6 months ]

Central Contacts and Locations

Central contacts

Edwin Thomas

215 554 3530 clinical@eleison-pharma.com

Locations

Innovative Clinical Research Institute

Recruiting

Whittier, California, United States, 90603

Contacts

Kirsten Bettino

562-652-6532 kbettino@airesearch.us

Principal Investigator:

Richy Agajanian, MD

Moffitt Cancer Center

Recruiting

Tampa, Florida, United States, 33612

Contacts

Michael Rowland

813-745-1157 michael.rowland@moffitt.org

Principal Investigator:

Richard Kim, MD

Gabrail Cancer Center Research

Recruiting

Canton, Ohio, United States, 44718

Contacts

Carrie Smith

330-417-8231 csmith@gabrailcancercenter.com

Principal Investigator:

Nashat Gabrail, MD

More Information

Sponsor

Eleison Pharmaceuticals LLC.

Last update posted

Dec 31, 2024

Last verified

Dec, 2024

Keywords

glufosfamide
5-FU
metastatic pancreatic adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Eleison Pharmaceuticals LLC. on 2024-12-31.