Study on FOLFIRINOX, 9-ING-41, and Losartan for Pancreatic Cancer

Sponsor: Colin D. Weekes, M.D., PhD

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05077800

Provider View

This clinical trial is exploring whether a new drug combination can prevent pancreatic cancer from becoming resistant to standard treatments. The study involves the drugs 9-ING-41, Losartan, and a chemotherapy regimen called FOLFIRINOX.

Patient Parameters

Program Overview

The aim of this study is to test if a new drug, 9-ING-41, can help prevent pancreatic cancer from resisting standard treatments. The study will also use Losartan, a blood pressure medication, and a chemotherapy combination called FOLFIRINOX, which includes four drugs: 5-Fluorouracil, Oxaliplatin, Irinotecan, and Leucovorin. Researchers want to see if these drugs together can keep the cancer from becoming resistant to treatment.

Description

This study is for adults with untreated metastatic pancreatic cancer. It will start with a Safety Run-In phase to check for side effects and ensure the treatment is safe. After that, the main part of the study will begin. The study is in Phase II, which means it is testing how well the treatment works.

The study involves using an investigational drug called 9-ING-41, which is not yet approved by the FDA for pancreatic cancer. This drug works by stopping an enzyme that helps cancer cells grow and resist chemotherapy. By blocking this enzyme, the study hopes to make chemotherapy more effective. FOLFIRINOX is a combination of four chemotherapy drugs that may help shrink pancreatic tumors. Losartan, usually used for high blood pressure, is included because it may help stop cancer cells from resisting chemotherapy.

Participants will go through screening to see if they qualify, receive the study treatment, and have follow-up visits. The treatment is divided into three parts: Complete therapy, Maintenance therapy, and Transition to complete therapy. Participants will be followed for up to 5 years after treatment.

Up to 70 people will participate in this study, which is supported by Actuate Therapeutics and funded by the Lustgarten Foundation.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with metastatic pancreatic cancer and not previously treated for it.
  • Have measurable cancer as defined by specific medical criteria.
  • Be 18 years or older.
  • Be in good overall health with a performance status score of 0 or 1.
  • Have adequate organ and bone marrow function based on specific blood tests.
  • Previous use of certain blood pressure medications is allowed, but may need to be changed if not part of the study treatment.
  • HIV-positive participants on effective treatment are eligible.
  • Participants with controlled hepatitis B or treated hepatitis C are eligible.
  • Participants with treated brain metastases are eligible if stable.
  • Participants with other cancers that do not interfere with the study are eligible.
  • Participants with heart disease must have a certain level of heart function.
  • Women of childbearing potential must use effective contraception during and after the study.
  • Must understand and agree to the study requirements and sign informed consent.

Exclusion Criteria

  • Previous treatment for pancreatic cancer, including chemotherapy, radiation, or immunotherapy.
  • Certain genetic mutations or cancer types that are not part of the study.
  • Major surgery within 4 weeks before starting the study.
  • Participation in another drug study within 4 weeks before starting the study.
  • Unresolved side effects from previous cancer treatments, except hair loss.
  • Allergic reactions to study drugs that cannot be managed.
  • Certain heart conditions or blood clotting disorders.
  • Use of certain medications that interact with study drugs.
  • Uncontrolled illnesses or conditions that could interfere with the study.
  • History of active tuberculosis.
  • Recent live vaccinations, except for certain flu and COVID vaccines.
  • Known genetic polymorphisms that affect drug metabolism.

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