LoginNew therapy for pancreatic cancer: Phase III clinical trial currently recruiting Australian patients
Currently there is a clinical trial that is recruiting patients from around the globe including sites across Australia. The trial is testing MM-398; a therapy that uses the latest in nanotechnology to deliver the chemotherapeutic agent irinotecan encased in a liposome to cancer patients.1 In particular this trial, named NAPOLI-1 (NAnoliPOsomaL Irinotecan) is recruiting patients with pancreatic cancer who have previously been treated with the chemotherapy agent gemcitabine unsuccessfully i.e. their disease has gone on to spread/progress despite this treatment.2,3
What is a clinical trial?
A clinical trial is a scientifically designed study to investigate the use of a treatment (e.g. medication) that requires patients to volunteer. They are a very important part of testing the safety and efficacy of medications prior to becoming available to the public. For many patients, clinical trials are an important step in accessing newly discovered therapies before they become generally available.4
NAPOLI-1 is a phase III clinical trial.3 This means that a large number of patients are involved to test whether one particular treatment is better than an alternative treatment. Because the number of patients involved is large, these studies give a better understanding of the potential side effects of the new treatment.4
Dr Andrew Dean, oncologist and Principal Investigator, said, “Taking part in this trial may give you an additional line therapy that wouldn’t normally be available.”
 | For more information on clinical trials, see Clinical Trials. |
What is MM-398?
The medication being tested in the NAPOLI-1 trial is MM-398. MM-398 uses the latest in nanotechnology to surround the chemotherapeutic drug (irinotecan) in a liposomal sphere. This can be thought of as a special capsule containing medication that travels within the blood stream. The capsule has special properties that have been designed to target cancer cells and be absorbed by them. This allows greater amounts of the anti-cancer drug to be delivered to tumour sites and minimises the exposure to normal tissues.1
Dr Dean said, “This type of technology has been used before to help the chemotherapy into the cancer cells and protect the body against some of the side effects. As the compound is actually new, we do not know for sure if it will work as planned, hence why we are conducting a clinical trial.”
What is NAPOLI-1?
The title of the clinical trial being performed is: NAPOLI-1 (NAnoliPOsomaL Irinotecan). This study is recruiting patients with metastatic pancreatic cancer who have previously been treated with the chemotherapeutic agent gemcitabine and have then gone on to have their cancer continue to grow and/or spread despite this treatment.1,2
Dr Dean said, “What is important about this trial, is that whatever arm of treatment you are allocated to, you are allocated to an active therapy – there is no placebo arm so everybody taking part receives active chemotherapy.”
The trial will compare three different treatment groups. One treatment group will receive MM-398 alone; one treatment group will receive an alternative chemotherapy regime consisting of two agents: 5-fluorouracil and leucovorin; and the final treatment group will be treated with all three agents: MM-398, 5-fluorouracil and leucovorin.5
Dr Dean said, “When you take part in the trial, you are allocated either to an older treatment which can be effective for pancreatic cancer called 5-FU, the new MM-398 on its own, or a combination of the two drugs together.”
The main aim (called the primary endpoint) is to compare the overall survival of patients between the three groups to see if one is superior to the others. The trial will also compare a number of other secondary endpoints between groups, including:2
- The amount of time between treatment and disease progression or death if any (progression free survival / time to treatment failure);
- The proportion of patients that have a reduction in their tumour burden;
- Quality of life as reported by a patient questionnaire;
- Safety and side effect profiles of the different medications;
- Further information on how each of the drugs are absorbed, distributed, metabolised and excreted by the body.
Dr Dean said, “In Australia, the only drug currently available on the Pharmaceutical Benefits Scheme specifically for the treatment of pancreatic cancer is gemcitabine. Some hospitals provide other drugs such as oxaliplatin and irinotecan but this is by no means available uniformly. An older treatment called 5-FU is also available on the PBS to treat a variety of gastrointestinal malignancies and this is used by some doctors when gemcitabine has stopped working. So taking part in this trial can give you access to an additional therapy that wouldn’t normally be available.”
The study opened in May 20123 and hopes to recruit greater than 400 participants from around the globe.6
Dr Dean said, “Any chemotherapy treatment, whether “standard” or otherwise has certain risks. When people are taking part in a clinical trial, they are monitored in a much more intensive fashion than normal. This is because extra safety precautions are used to look out for any side effects or problems that have not previously been described.”
How can I become involved?
To be involved in any clinical trial, there are certain criteria (inclusion criteria) that need to be met. This is to ensure that the trial is testing the different treatments in a similar group of patients that are appropriate for treatment with that particular medication.8 There are also certain factors (exclusion criteria) that may exclude you from being able to safely and effectively participate in the study.9
To help you determine if you are suitable to participate in the NAPOLI-1 (NAnoliPOsomaL Irinotecan) trial, we have developed a checklist. You will need to discuss this with your treating Doctor as there are several blood test results that must meet certain criteria. Your Doctor can also clarify any points that are unclear to you.
 | Download the NAPOLI-1 eligibility checklist. |
References
- MM-398 [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
- NAPOLI-1 [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
- Victorian Cancer Trials Link. NAPOLI 1 [online]. Cancer Council Victoria; [cited 12 June 2013]. Available from: [URL link]
- Clinical trials [online]. Virtual Medical Centre; [cited 28 June 2013]. Available from: [URL link]
- NAPOLI-1 Study Design [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
- EU Clinical Trials Registry [online]. European Medicines Agency; [cited 12 June 2013]. Available from: [URL link]
- Inclusion Criteria [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
- Exclusion Criteria [online]. Merrimack Pharmaceuticals Inc; 2013 [cited 7 June 2013]. Available from: [URL link]
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