Study on SGT-53 Combined with Gemcitabine and Nab-Paclitaxel for Treating Metastatic Pancreatic Cancer

Sponsor: SynerGene Therapeutics, Inc.

Sponsor score: 0

ClinicalTrials ID:NCT02340117

Provider View

This clinical trial is testing a new treatment combination of SGT-53 with gemcitabine and nab-paclitaxel to see if it is safe and effective for patients with metastatic pancreatic cancer. The study aims to find out if this combination can help control the cancer and improve patient outcomes.

Patient Parameters

Program Overview

This study is exploring a new treatment for metastatic pancreatic cancer using a combination of SGT-53, gemcitabine, and nab-paclitaxel. SGT-53 is designed to restore the function of a gene called p53, which helps control cell growth and death. Many cancers, including pancreatic cancer, have problems with this gene, making them harder to treat. By combining SGT-53 with chemotherapy drugs gemcitabine and nab-paclitaxel, researchers hope to improve treatment effectiveness and patient survival. The study will evaluate how well this combination works, how long patients live without the cancer getting worse, and the safety of the treatment.

Description

The p53 gene is important for controlling cell growth and preventing cancer. When this gene doesn't work properly, it can make cancer treatments less effective. SGT-53 is a therapy that aims to fix the p53 gene in cancer cells, potentially making them more responsive to treatment. This study combines SGT-53 with two chemotherapy drugs, gemcitabine and nab-paclitaxel, to treat patients with metastatic pancreatic cancer. Researchers will look at how well the treatment works, how long patients live without the cancer progressing, and any side effects. The goal is to see if this combination can improve outcomes for patients with this aggressive cancer.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage IV metastatic pancreatic cancer.
  • Have at least one tumor that can be measured by a CT scan.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have a life expectancy of at least 3 months.
  • Be 18 years or older.
  • Provide signed, written informed consent.
  • Women of childbearing potential must have a negative pregnancy test.
  • Have acceptable liver function, with specific limits on bilirubin, AST, ALT, and serum creatinine levels.
  • Have adequate blood cell counts, including neutrophils, platelets, and hemoglobin.
  • Have controlled blood sugar levels.
  • Have no significant abnormalities in urinalysis.
  • Have normal blood clotting times.
  • Agree to use effective contraception during the study.
  • Not have received prior chemotherapy or investigational therapy for metastatic disease, except for specific cases where prior treatment with FOLFIRINOX or gemcitabine is allowed under certain conditions.

Exclusion Criteria

  • Have received prior chemotherapy for pancreatic cancer, except for specific cases with FOLFIRINOX or gemcitabine under certain conditions.
  • Have severe heart disease or recent heart attack.
  • Have active, uncontrolled infections.
  • Have a fever over 38.1°C.
  • Have blood cancers.
  • Have high blood pressure that is not controlled.
  • Be pregnant or breastfeeding.
  • Have had recent surgery, radiation, or investigational therapy.
  • Have known infections like HIV, Hepatitis B, or Hepatitis C.
  • Have serious non-cancerous diseases that could affect the study.
  • Be taking other investigational drugs or certain medications like Coumadin.
  • Be on systemic steroids or immunosuppressive medications recently.
  • Have had recent strokes or uncontrolled heart failure.
  • Have significant nerve problems or require dialysis.
  • Have had severe reactions to gemcitabine or nab-paclitaxel.

Locations

FACILITYZIPCITYSTATE
Mary Crowley Cancer Research Center75201DallasTexas

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.