A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic… (NCT07026279) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A Study of Narmafotinib Given in Combination With Modified FOLFIRINOX in Patients With Metastatic Pancreatic Cancer
Australia67 participantsStarted 2025-08-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged at least 18 years at the time of consent.
* Confirmed diagnosis of metastatic pancreatic adenocarcinoma (PDAC) within the 6 weeks prior to study start and have not received treatment for metastatic PDAC.
* Have measurable disease by RECIST v1.1.
* Eligible for treatment with mFOLFIRINOX as standard of care therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1
* Have a life expectancy of \> 3 months.
* Adequate organ function
* Agree to use effective contraception.
Exclusion Criteria:
* Pregnant or breast-feeding
* Have received any investigational medicinal product (IMP) within 30 days or 5 half-lives (whichever is longer) prior to Day -7.
* Neuroendocrine or acinar cell pancreas tumors.
* Known brain metastases.
* Conditions that could interfere with the swallowing or absorption of study medication.
* Received previous radiotherapy, surgery, chemotherapy, or investigational therapy for the treatment of metastatic disease.
* Received cytotoxic doses of any 5-FU based chemotherapy.
* Any chemotherapy related toxicities greater than grade 1 from prior neoadjuvant or adjuvant therapy for PDAC.
* Human immunodeficiency virus (HIV) infection and/or history of Hepatitis B infection or known to have active hepatitis B or C.
* Uncontrolled angina, myocardial infarction, coronary stenting, stroke, or cerebrovascular accident within 1-year prior to the first dose of study drug.
* History of interstitial lung disease, history of s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) from Baseline to End of Study
Timeframe: From first dose of study drug to end of study, an expected average of 6 months
2
Part B: identification of optimal dose of narmafotinib
Timeframe: From first dose of study drug to end of study, an expected average of 6 months