Study on CEND-1 with Chemotherapy and Optional Panitumumab for Pancreatic, Colon, and Appendix Cancers

Sponsor: Anup Kasi

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05121038

Provider View

This clinical trial is testing the safety of a new treatment combination using CEND-1 with chemotherapy drugs FOLFIRINOX, with or without Panitumumab, for patients with pancreatic, colon, and appendix cancers.

Patient Parameters

Program Overview

The purpose of this study is to ensure the safety of a new treatment combination involving CEND-1 and chemotherapy drugs FOLFIRINOX, with or without Panitumumab, for treating pancreatic, colon, and appendix cancers. This trial is in its early phases (Phase IB/IIA) and aims to determine if this combination can be safely administered to patients.

Eligibility Criteria

Inclusion Criteria

  • Ability to understand the study and willingness to sign a consent form.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have one or more tumors that can be measured by MRI, PET/CT, or CT scan.
  • Diagnosed with pancreatic, colon, or appendix cancer.
  • For pancreatic cancer patients:
    • Resectable cancer with no spread to distant organs and no major blood vessel involvement.
    • Borderline resectable cancer with specific conditions regarding blood vessel involvement.
  • For colorectal or appendix cancer patients:
    • Peritoneal metastases or limited spread to other organs that can be surgically removed.
  • Eligible for treatment with FOLFIRINOX, with or without Panitumumab.
  • Expected to live at least 3 more months.
  • Willing to provide a tumor sample for testing or undergo a biopsy.
  • Fit for major abdominal surgery after treatment.
  • Women of childbearing potential must have a negative pregnancy test before joining the study.
  • Have adequate organ function.

Exclusion Criteria

  • Currently participating in another clinical trial.
  • Using any other cancer treatments, including chemotherapy, targeted therapy, or immunotherapy.
  • Received chemotherapy or investigational cancer treatments within the last 2 years.
  • Have a psychiatric condition or social situation that would make it difficult to follow the study requirements.
  • Pregnant or breastfeeding.
  • Allergic to any ingredients in the study drugs.
  • Have a severe infection within 2 weeks before starting the study treatment.
  • Have serious heart conditions or recent heart attack.
  • Have an active infection with HIV, hepatitis B, or hepatitis C.
  • Have a serious non-cancerous disease that could interfere with the study.
  • Have known brain metastases.
  • Have another active cancer, except for certain skin, cervical, or prostate conditions that have been treated and inactive for over 3 years.

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