A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer
NCT07026279 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2026-05-05
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.
Conditions
- Pancreatic Cancer Metastatic
Interventions
- DRUG
-
narmafotinib ascending doses
once daily capsules
- DRUG
-
narmafotinib dose comparison
once daily capsules
Sponsors & Collaborators
-
Amplia Therapeutics Limited
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-08-18
- Primary Completion
- 2029-07-31
- Completion
- 2029-07-31
- FDA Drug
- Yes
Countries
- Australia
Study Locations
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