Glufosfamide Versus 5-FU in Second Line Metastatic Pancreatic Cancer
ConditionMetastatic Pancreatic Adenocarcinoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEleison Pharmaceuticals LLC.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Glufosfamide
DrugGlufosfamide: 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
DrugFluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
Treatment groups
480 Participants
are divided into 2 treatment groupsGroup A: glufosfamideExperimental treatment 1 intervention
Group B: 5-FUActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival
Time from Randomization to death from any cause
Time frame
Approximately 3-6 monthsSponsors and contacts
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Source ClinicalTrials.gov