Trial 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).
Status: OPEN for recruitment
Trial identifier: NCT07026279
Sponsor: Amplia Therapeutics Limited
Phase: I/II
Diagnosis: Metastatic (Stage IV) pancreatic ductal adenocarcinoma
Line of therapy: First-line
Treatment: Focal adhesion kinase (FAK) inhibitor AMP945 (oral) given prior to dosing with FOLFIRINOX (chemotherapy)
  • Key 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.
  • Key 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 tumours.
    • 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 slowly progressive dyspnoea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, or pulmonary hypersensitivity pneumonitis.

AMPLICITY (AMP945-202)

Locations: Epworth Richmond, Epworth Freemasons (East Melbourne), Epworth Eastern (Box Hill).

Epworth PI: Dr Prasad Cooray

Jreissati Pancreatic Centre at Epworth 

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