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A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer
Sponsor: Amplia Therapeutics Limited
Summary
This study is testing narmafotinib, a type of drug called a focal adhesion kinase (FAK) inhibitor, when it is given in combination with 4 chemotherapy drugs in a regimen called FOLFIRINOX, to patients who have pancreatic cancer which has metastasised (spread). The study is being run in 2 parts. Part A will test increasing dose levels of narmafotinib in at least 3 people per dose at up to 4 dose levels to assess safety. Part B will test 2 of the dose levels from Part A in 20 people per dose, to select the best dose to take forward into future studies. Participants will take narmafotinib as oral capsules every day. They will also receive mFOLFIRINOX chemotherapy on Day 1 and and Day 15 of 28-day cycles.
Official title: A Phase 1b/2a, Multicenter, Open Label Study of the Safety, Efficacy and Pharmacokinetics of Narmafotinib in Combination With Modified FOLFIRINOX in Pancreatic Cancer Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2025-08-18
Completion Date
2029-07
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
narmafotinib ascending doses
once daily capsules
narmafotinib dose comparison
once daily capsules
Locations (7)
UC Irvine Chao Family Cancer Centre
Orange, California, United States
University of Florida Shands
Gainesville, Florida, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Vanderbilt University Medical Centre
Nashville, Tennessee, United States
GenesisCare
St Leonards, New South Wales, Australia
Epworth Healthcare
Richmond, Victoria, Australia