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Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

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.
 
ClinicalTrials.gov Identifier: NCT01954992
Recruitment Status : Recruiting
First Posted : October 7, 2013
Last Update Posted : May 10, 2021
Sponsor:
Information provided by (Responsible Party):
Eleison Pharmaceuticals LLC.

Tracking Information
First Submitted Date  ICMJE September 27, 2013
First Posted Date  ICMJE October 7, 2013
Last Update Posted Date May 10, 2021
Study Start Date  ICMJE April 2014
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2013)		 Overall Survival [ Time Frame: Approximately 3-6 months ]
Time from Randomization to death from any cause
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Pancreatic Adenocarcinoma
Intervention  ICMJE
  • 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.
  • Drug: Fluorouracil
    Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
    Other Name: 5-FU
Study Arms  ICMJE
  • Experimental: glufosfamide
    Glufosfamide: 4500 mg/m2 IV over 6 hours on Day 1 of each 21-day cycle
    Intervention: Drug: Glufosfamide
  • Active Comparator: 5-FU
    Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
    Intervention: Drug: Fluorouracil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2013)		 480
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date December 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Edwin Thomas 215 554 3530 clinical@eleison-pharma.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01954992
Other Study ID Numbers  ICMJE EP-GF-301
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Eleison Pharmaceuticals LLC.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eleison Pharmaceuticals LLC.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Edwin Thomas Eleison Pharmaceuticals
PRS Account Eleison Pharmaceuticals LLC.
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP