MM398 first line in metastatic pancreatic cancer
Research type
Research Study
Full title
A Randomised, Open-label Phase 2 Study of Nanoliposomal Irinotecan (nal-IRI) containing Regimens versus nab-Paclitaxel plus Gemcitabine in Patients with Previously Untreated, Metastatic Pancreatic Adenocarcinoma
IRAS ID
196157
Contact name
Sheetal Dyall
Contact email
Sponsor organisation
Merrimack Pharmaceuticals, Inc.
Eudract number
2015-003086-28
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND number, 102799
Duration of Study in the UK
1 years, 4 months, 18 days
Research summary
Pancreatic cancer is one of the leading causes of cancer death. The location of the tumour generally results in few early symptoms, so it is often diagnosed at a late stage. Currently there are no effective screening tools, and there is a limited understanding of risk factors, so that means that at the time of diagnosis, patients usually present with advanced or metastatic disease (that is cancer that has spread to other parts of the body).
Pancreatic cancer therapies for advanced or metastatic disease are limited, and usually prolong survival for less than a year. The most common two combination chemotherapy regimens currently used if you've never been treated for metastatic pancreatic cancer are:-
5-fluorouricil (5-FU)/leucovorin (LV) + irinotecan + oxaliplatin
nab-paclitaxel + gemcitabine. Thus, new treatment options are needed.Irinotecan is a chemotherapy that works by preventing uncontrolled cell growth, however, can cause severe side effects. Nal-IRI (MM-398) is a novel formulation of irinotecan designed to improve its anticancer effects by better delivery to the tumours, without worsening of its side effects.
The study will be conducted in 2 parts. Part 1 will look at the safety of naI-IRI when given together with 5FU/LV and oxaliplatin. The reason for Part 1 is to identify the safest and highest dose of this combination treatment to be used in Part 2 of the study.
Part 2 is to assess how effective and safe naI-IRI is at treating metastatic pancreatic cancer that has not been treated previously. This will be done by comparing the effects of the naI-IRI together with 5FU/LV with or without oxaliplatin, against the effects of nab-paclitaxel and gemcitabine. Participants will be randomly allocated to one of three treatment arms as below, and will have an equal chance (1 in 3) of being placed in any one of these treatment arms:-
Arm 1: nal-IRI + 5-FU/LV + oxaliplatin
Arm 2: nal-IRI + 5-FU/LV
Arm 3: nab-paclitaxel + gemcitabine.This is an open-label study, which means that participants will know the treatment they are receiving.
A total of 156 to 168 participants will be enrolled globally, with 150 of those participants being recruited for Part 2. In the UK, participants will take part in Part 2.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
16/NE/0084
Date of REC Opinion
3 Jun 2016
REC opinion
Further Information Favourable Opinion