Date: 2015-10-27
Type of information: Recruitment of the first patient
phase: 2
Announcement: recruitment of the first patient
Company: Baxalta (USA - IL) Merrimack Pharmaceuticals (USA - MA)
Product: Onivyde™ (MM-398 - nanoliposomal irinotecan injection)
Action
mechanism: topoisomerase I inhibitor. MM-398 is a novel encapsulation of irinotecan in a long-circulating nanoliposomal formulation designed to increase drug deposition and prolong cytotoxic effects, with the goal of improving its anti-cancer properties. In May 2014, Merrimack announced that the Phase 3 trial, known as NAPOLI-1, studying MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints for patients with metastatic pancreatic cancer who were previously treated with a gemcitabine-based therapy. In the study, the combination of MM-398 with 5-FU and leucovorin demonstrated a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control arm of 5-FU and leucovorin alone.
Disease: previously untreated, metastatic pancreatic adenocarcinoma
Therapeutic area: Cancer - Oncology
Country: Australia, USA
Trial
details: The study is an open-label, phase 2 comparative study to assess the safety, tolerability, and efficacy of nanoliposomal irinotecan injection (nal-IRI) in combination with other anticancer therapies, compared to nab-paclitaxel + gemcitabine, in patients with advanced pancreatic adenocarcinoma who have not received prior chemotherapy. This study will assess the following regimens: - nal-IRI +n - 5-FU/LV + oxaliplatinal-IRI + 5-FU/LV - nab-paclitaxel + gemcitabine The study will be conducted in two parts: a safety run-in of the nal-IRI + 5-FU/LV + oxaliplatin regimen, and a randomized, efficacy study of nal-IRI + 5-FU/LV + oxaliplatin, and nal-IRI + 5-FU/LV, versus nab-paclitaxel + gemcitabine. (NCT02551991)
Latest
news: * On October 27, 2015, Merrimack Pharmaceuticals and Baxalta announced the enrollment of the first patient in an exploratory Phase 2 clinical study of Onivyde™ (irinotecan liposome injection) in previously untreated, metastatic pancreatic adenocarcinoma. The Phase 2 clinical study of Onivyde™ in patients with previously untreated, metastatic pancreatic adenocarcinoma will assess the safety and efficacy of the combination of Onivyde™ plus fluorouracil (5-FU) and leucovorin (LV), with or without the addition of oxaliplatin, versus nab-paclitaxel and gemcitabine. In the first part of the study, approximately 6-18 patients will be enrolled. The primary outcome for Part 1 of the study is to evaluate the safety and tolerability of Onivyde™ in combination with 5-FU/LV and oxaliplatin. In the second part of the study, an additional 150 patients (50 patients per arm) with previously untreated, metastatic pancreatic adenocarcinoma will be enrolled and randomized to receive either Onivyde™ in combination with 5-FU/LV and oxaliplatin, Onivyde™ in combination with 5-FU/LV, or nab-paclitaxel and gemcitabine. In Part 2, efficacy of the Onivyde™ containing regimens will be compared to the nab-paclitaxel and gemcitabine regimen, evaluating progression free survival (PFS) rate at 24 weeks, as well as overall survival, PFS, objective response rate, tumor marker CA19-9 response, safety and tolerability. Merrimack and Baxalta plan to conduct the study at sites in the United States, Canada, Europe, Australia, New Zealand, Taiwan and South Korea. The first patient in the study was dosed at St. John of God Subiaco Hospital in Subiaco , Western Australia .
