Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer

Part of paid clinical trials in Whittier, California.

Sponsor
Eleison Pharmaceuticals LLC.
Study ID
NCT01954992
Phase
PHASE3
Status
Recruiting
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Conditions

  • Metastatic Pancreatic Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Apr 30, 2014
Status verified
Dec 2024
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

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

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Innovative Clinical Research InstituteWhittierCalifornia90603
Kirsten Bettino
[email protected]
562-652-6532
Richy Agajanian, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Michael Rowland
[email protected]
813-745-1157
Richard Kim, MD (PRINCIPAL_INVESTIGATOR)
Gabrail Cancer Center ResearchCantonOhio44718
Carrie Smith
[email protected]
330-417-8231
Nashat Gabrail, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Innovative Clinical Research Institute· Whittier, CAMoffitt Cancer Center· Tampa, FLGabrail Cancer Center Research· Canton, OH

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