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Trial record 1 of 1 for:    EP-GF-301
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Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Eleison Pharmaceuticals LLC.
Sponsor:
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.
ClinicalTrials.gov Identifier:
NCT01954992
First received: September 27, 2013
Last updated: February 23, 2017
Last verified: February 2017
  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: No masking
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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 27, 2013
Last Updated: February 23, 2017

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

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

ClinicalTrials.gov processed this record on May 25, 2017