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NAPOLI-1 (NAnoliPOsomaL Irinotecan) – A Phase III clinical trial investigating the use of nanotechnology (MM-398) in pancreatic cancer

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The latest approach to combat cancer cells is the use of nanotechnology to selectively deliver higher quantities of chemotherapy, increasing the delivery of such agents to tumour sites and minimise exposure to healthy tissue.1 Currently, there is a phase III clinical trial investigating the use of MM-398 in patients with metastatic pancreatic cancer.2-5 

MM-398 is a novel agent that uses nanotechnology to incorporate the chemotherapeutic agent irinotecan in a liposomal sphere.  The liposome is thought to be preferentially directed to tumour sites by way of the newly developed tumour blood flow, minimising exposure to non-cancerous cells. At the tumour site, preclinical studies have shown MM-398 to be absorbed into the tumour. This could translate to larger quantities of chemotherapy being delivered to tumour sites compared to conventional therapy.1

Dr Andrew Dean, oncologist and Principal Investigator said, “There are numerous examples of drugs which have been modified using nanotechnology to produce either a more effective drug or protect the body from side-effects.”

“One example is doxorubicin (adriamycin). It is highly toxic, but when nanotechnology is applied to this drug, to create pegylated liposomal doxorubicin, a lot of the side effects (including bone marrow suppression, risk of leukaemia in later life and weakening of heart muscle) have been bypassed. It is possible to give this drug monthly sometimes for several years without experiencing cardiotoxicity or significant bone marrow suppression.”

The trial: NAPOLI-1 (NAnoliPOsomaL Irinotecan), is an interventional study6 consisting of an open label, randomised phase 3 study. 2-5  NAPOLI is recruiting patients from around the globe with metastatic pancreatic cancer which has previously failed gemcitabine-based therapy.2 The primary objective is to compare overall survival between its three treatment arms:3

  • Experimental arm: MM-398 alone
  • Experimental arm: MM-398, 5-fluorouracil and leucovorin
  • Control arm: 5-fluorouracil and leucovorin  

Randomisation will occur using an Interactive Web Response System and will stratify patients according several prognostic indicators including ethnicity, baseline albumin levels and Karnofsky Performance Status.3

The trial will also compare several secondary objectives between treatment groups including:6

  • Progression free survival
  • Time to treatment failure
  • Objective response rate
  • Response of the tumour marker CA 19-9
  • Clinical benefit response
  • Quality of life scores

The pharmacokinetics as well as biomarkers associated with toxicity and efficacy post-treatment with MM-398 and MM-398 plus 5-fluorouracil and leucovorin will also be explored.6

The study opened in May 20124 and hopes to recruit greater than 400 participants from around the globe.  Some of the sites involved include: Argentina, Australia, Brazil, Canada, Czech Republic, France, Germany, Hungary, India, Italy, Republic of Korea, Russian Federation, South Africa, Spain, Taiwan, United Kingdom and the United States.2

More information on MM-398 and NAPOLI-1 including inclusion/exclusion criteria and Australia trial sites.



  1. MM-398 [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
  2. EU Clinical Trials Registry [online]. European Medicines Agency; [cited 12 June 2013]. Available from: [URL link]
  3. NAPOLI-1 Study Design [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
  4. Victorian Cancer Trials Link. NAPOLI 1 [online]. Cancer Council Victoria; [cited 12 June 2013]. Available from: [URL link]
  5. Cancer Clinical Trials Open in Western Australia [online]. Cancer Council Western Australia; 11 May 2013 [cited 12 June 2013]. Available from: [URL link]
  6. NAPOLI-1 [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]

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Posted On: 23 July, 2013
Modified On: 28 August, 2014

Created by: myVMC