Brief 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 chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells drugs in a regimen called FOLFIRINOX, to patients who have pancreatic cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs which has metastasised (spread). The study is being run in 2 parts.
Part A will test increasing dosethe amount of medication taken 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.
Intervention / Treatment
- Drug: Narmafotinib ascending doses
- Drug: Narmafotinib dose comparison
Inclusion Criteria:
- Aged at least 18 years at the time of consent.
- Confirmed diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of metastatic pancreatic adenocarcinomacancer arising from mucus-producing glands in organs (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 Oncologythe study, diagnosis and treatment of cancer Group (ECOG) Performance Score of 0 or 1
- Have a life expectancy of > 3 months.
- Adequate organ function.
- Agree to use effective contraception.