Study on Narmafotinib with Chemotherapy for Patients with Metastatic Pancreatic Cancer

Sponsor: Amplia Therapeutics Limited

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07026279

Provider View

This clinical trial is testing a new drug, narmafotinib, combined with a chemotherapy regimen called FOLFIRINOX, to treat patients with pancreatic cancer that has spread to other parts of the body.

Patient Parameters

Program Overview

The study aims to evaluate the safety and effectiveness of narmafotinib, a drug that targets specific cancer cell functions, when used alongside a chemotherapy treatment known as FOLFIRINOX in patients with metastatic pancreatic cancer. The study is divided into two parts: Part A will test different doses of narmafotinib to find a safe dose, while Part B will further test two selected doses to determine the best one for future research. Participants will take narmafotinib capsules daily and receive chemotherapy on specific days of a 28-day cycle.

Eligibility Criteria

Inclusion Criteria

  • Be at least 18 years old.
  • Have a confirmed diagnosis of metastatic pancreatic cancer within the last 6 weeks and have not yet received treatment for it.
  • Have cancer that can be measured using standard criteria.
  • Be eligible for treatment with mFOLFIRINOX, a standard chemotherapy regimen.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have a life expectancy of more than 3 months.
  • Have adequate organ function as determined by medical tests.
  • Agree to use effective contraception during the study.

Exclusion Criteria

  • Be pregnant or breastfeeding.
  • Have taken any experimental drugs within 30 days or 5 half-lives before starting the study.
  • Have a type of pancreatic tumor that is not adenocarcinoma.
  • Have known cancer spread to the brain.
  • Have conditions that affect swallowing or absorbing the study medication.
  • Have received previous treatments for metastatic cancer.
  • Have had certain chemotherapy treatments before.
  • Have unresolved side effects from previous cancer treatments.
  • Have HIV or active hepatitis B or C infections.
  • Have had recent serious heart or brain conditions.
  • Have certain lung diseases or breathing problems.
  • Have active infections at the start of the study.
  • Have allergies to the study drugs that cannot be managed.
  • Have any conditions listed in the warnings of the chemotherapy drugs used in the study.
  • Have significant nerve damage.
  • Have previously taken narmafotinib or similar drugs within the last 2 years.

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