Study Comparing Glufosfamide and 5-FU for Second Line Treatment in Metastatic Pancreatic Cancer

Sponsor: Eleison Pharmaceuticals LLC.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01954992

Provider View

This clinical trial is testing whether the drug glufosfamide can help patients with metastatic pancreatic cancer live longer compared to the standard treatment with 5-FU, after their cancer has worsened despite initial treatment with gemcitabine.

Patient Parameters

Program Overview

The purpose of this study is to find out if glufosfamide can provide a survival benefit for patients with metastatic pancreatic cancer who have already been treated with gemcitabine but whose cancer has continued to progress. The study compares glufosfamide to the standard treatment with 5-FU to see which is more effective in extending patients' lives.

Eligibility Criteria

Inclusion Criteria

  • Must be at least 18 years old.
  • Have a confirmed diagnosis of pancreatic adenocarcinoma through a biopsy or other medical test.
  • Have metastatic pancreatic cancer, meaning the cancer has spread to other parts of the body.
  • The cancer must have worsened during or after treatment with gemcitabine.
  • Have measurable or non-measurable cancer according to specific medical criteria.
  • Must have recovered from any side effects of previous treatments.
  • Be in good overall health with a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Agree to use effective birth control methods during the study and for six months after the last dose of chemotherapy.
  • Understand the study and agree to sign a written informed consent form.

Exclusion Criteria

  • Have received more than one previous treatment regimen for metastatic pancreatic cancer.
  • Have received any cancer treatment within 14 days before starting the study.
  • Have insulin-dependent diabetes, although type 2 diabetes controlled with oral medications is allowed.
  • Have cancer that has spread to the brain and is causing symptoms.
  • Have an active infection requiring antibiotics.
  • Be HIV positive or have active hepatitis B or C.
  • Have had recent heart problems or symptoms of heart disease.
  • Have another active cancer within the past year, except for certain skin cancers.
  • Have had major surgery within three weeks before starting the study and not fully recovered.
  • Have significant abnormalities in blood tests, such as low blood cell counts or high liver enzymes.
  • Be pregnant or breastfeeding.
  • Have participated in another clinical trial within 14 days before starting this study.
  • Have any condition that could interfere with the study or pose a risk to the patient.
  • Have a history or condition that could lead to kidney problems during the study.
  • Be unable or unwilling to undergo multiple CT scans.
  • Be unable or unwilling to comply with the study requirements for any reason.

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