Merrimack Pharmaceuticals, a biopharmaceutical company, has expanded the Phase 3 NAPOLI-1 study of MM-398 in late-stage pancreatic cancer to include an additional arm that combines MM-398 with 5-fluorouracil (5-FU) and leucovorin (folinic acid) (LV).
MM-398, a stable nanoliposomal encapsulation of the conventional chemotherapy irinotecan, is designed to optimise the delivery of irinotecan by extending the duration of circulation in the body and preferentially activating the drug within the tumour to achieve higher levels of the active drug, SN-38.
Merrimack vice president and MM-398 medical director, Eliel Bayever, said that expanding the trial will greatly enhance the design and long-term ability to favourably impact patients with the disease.
"Physicians have increasingly been utilising combination treatments for patients with second-line pancreatic cancer if they feel that the patient is well enough to tolerate more aggressive treatment," Bayever added.
The randomised, open-label study will begin enrolment on the amended protocol in July 2012.
The study is designed to enrol 405 patients at over 100 sites in North America, South America, Europe, Asia, Australia and South Africa.
According to the company, the protocol amendment enlarges the study population by 135 patients, calling for a total enrolment of 405 patients equally randomised across the three arms: MM-398 as a monotherapy and MM-398 in combination with 5-FU/LV, compared with the shared control arm of 5-FU/LV.
Merrimack development executive vice president, Clet Niyikiza, said: "We feel that adding the additional combination arm at this time takes advantage of the global infrastructure and momentum that we have in place, while efficiently testing two MM-398 regimens within a single study to more broadly explore its use in pancreatic cancer."