Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

NCT01954992 | Recruiting Phase 3 DMC

• 1 other identifier: EP-GF-301
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 3

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

Keywords

glufosfamide; 5-FU; metastatic pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Time from Randomization to death from any cause

  Approximately 3-6 months

Study Arms (2)

glufosfamide

EXPERIMENTAL

Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle

Drug: Glufosfamide

5-FU

ACTIVE COMPARATOR

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

Drug: Fluorouracil

Interventions

Glufosfamide DRUG

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.

glufosfamide

Fluorouracil DRUG

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

Also known as: 5-FU

5-FU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Eleison Pharmaceuticals LLC.: lead

Study Sites (3)

Innovative Clinical Research Institute

Whittier, California, 90603, United States

RECRUITING

Moffitt Cancer Center

Tampa, Florida, 33612, United States

RECRUITING

Gabrail Cancer Center Research

Canton, Ohio, 44718, United States

RECRUITING

MeSH Terms

Interventions

beta-D-glucosylisophosphoramide mustard; Fluorouracil

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Edwin Thomas

  Eleison Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Edwin Thomas

CONTACT

215 554 3530; clinical@eleison-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 27, 2013
• First Posted: October 7, 2013
• Study Start: April 1, 2014
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

US (3)