Phase 2A Pilot Study of C3 Treatment for Advanced Pancreatic Cancer That Has Returned or Not Responded to Treatment

Sponsor: State University of New York - Downstate Medical Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06030622

Provider View

This clinical trial is testing a new combination of medications, called C3, with Gemcitabine to see if it is safe and effective in treating advanced pancreatic cancer that has come back or not responded to previous treatments.

Patient Parameters

Program Overview

The main goals of this study are to find out if the combination of C3 (metformin, digoxin, and simvastatin) with Gemcitabine is safe and can help control advanced pancreatic cancer. Researchers also want to see if this treatment can help patients live longer. Participants will take C3 medications along with Gemcitabine for up to two years. If patients choose not to take Gemcitabine, they can still receive the C3 medications.

Description

Pancreatic cancer is one of the most deadly cancers, with many people diagnosed each year. Current treatments for advanced pancreatic cancer, like Gemcitabine, often only help for a short time. Recent studies suggest that using metformin and simvastatin may improve survival in pancreatic cancer patients.

This study will test a new treatment combination called C3, which includes metformin, digoxin, and simvastatin, in 25 patients with advanced pancreatic cancer that has returned or not responded to previous treatments. The study will check if this combination is safe and if it can help control the cancer.

Participants will take C3 medications as pills, along with their usual treatment, Gemcitabine. The first few patients will receive the C3 medications for 28 days to check for any side effects. If the treatment is safe, more patients will join the study. If side effects occur, the dose may be lowered. If patients do not want to take Gemcitabine, they can choose to take only the C3 medications.

Throughout the study, doctors will monitor patients' health with physical exams, blood tests, and scans to check for any side effects and to see how the cancer is responding to the treatment. The study aims to find out if this new combination can improve outcomes for patients with advanced pancreatic cancer.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with confirmed pancreatic cancer.
  • Cancer that has not responded to or has returned after at least one standard treatment.
  • Good overall health with a performance status score of 0 or 1.
  • Available tissue sample for specific protein level evaluation.
  • Adequate blood cell counts and organ function based on specific tests.
  • Recovery from previous treatment side effects to a certain level.
  • Negative pregnancy test for women of childbearing potential.
  • Ability to understand and sign a consent form.
  • Willingness to follow the study protocol, including treatment and visits.
  • No active infections at the time of joining the study.

Exclusion Criteria

  • Recent cancer treatments within a specified time before starting the study.
  • History of other cancers unless treated and disease-free for at least 3 years.
  • Untreated or progressing brain metastases.
  • History of muscle breakdown (rhabdomyolysis).
  • Medical or mental health conditions that could interfere with the study.
  • Chronic hepatitis B or C infection.
  • Active infection requiring antibiotics.
  • Severe allergies or intolerance to study medications.
  • Significant heart conditions unless cleared by a cardiologist.
  • Pregnant or nursing women.
  • Any condition that could affect the study results or patient safety.
  • Cognitive impairment or reduced capacity to consent.

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