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Trial record 1 of 1 for:    Glufosfamide Compared with Fluorouracil (5-FU)
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Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

This study is currently recruiting participants.
Verified February 2017 by Eleison Pharmaceuticals LLC.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01954992
First Posted: October 7, 2013
Last Update Posted: February 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
  Purpose
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.

Condition Intervention Phase
Metastatic Pancreatic Adenocarcinoma Drug: Glufosfamide Drug: Fluorouracil Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eleison Pharmaceuticals LLC.:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Approximately 3-6 months ]
    Time from Randomization to death from any cause


Estimated Enrollment: 480
Study Start Date: September 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 5-FU

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954992


Contacts
Contact: Edwin Thomas 215 554 3530 clinical@eleison-pharma.com

  Show 22 Study Locations
Sponsors and Collaborators
Eleison Pharmaceuticals LLC.
Investigators
Study Director: Edwin Thomas Eleison Pharmaceuticals
  More Information

Responsible Party: Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier: NCT01954992     History of Changes
Other Study ID Numbers: EP-GF-301
First Submitted: September 27, 2013
First Posted: October 7, 2013
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Eleison Pharmaceuticals LLC.:
glufosfamide
5-FU
metastatic pancreatic adenocarcinoma

Additional relevant MeSH terms:
Fluorouracil
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Ifosfamide
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents