Merrimack MM-398 vs. 5-FU & Leucovorin in Metastatic Pancreatic Cancer
Research type
Research Study
Full title
NAPOLI 1: A Randomized, Open Label Phase 3 Study of MM-398 versus 5- Fluorouracil and Leucovorin in Patients with Metastatic Pancreatic Cancer
IRAS ID
94112
Contact name
David Cunningham
Sponsor organisation
Merrimack Pharmaceuticals Inc
Eudract number
2011-004687-30
Clinicaltrials.gov Identifier
Research summary
Pancreatic cancer is currently the fourth leading cause of cancer death in the United States. A drug called gemcitabine is the current standard of care in first line treatment of advanced and pancreatic cancer that has spread (metastatic). Most patients with metastatic pancreatic cancer progress following treatment with gemcitabine-based therapy. There is no standard of care for this population. This study will compare overall survival following treatment with MM-398 versus flurouracil and leucovorin in patients with metastatic pancreatic cancer that have progressed on gemcitabine-based therapy. MM-398 is experimentalflurouracil and leucovorin are approved for cancer treatment. In complete and ongoing preclinical studies, promising anti-tumour activity has been observed with MM-398. Clinical data suggests MM-398 may be a viable option for this late stage population, especially in respect to 6 month and 1 year survival rates. All patients will participate in up to 28 days of screening. Eligible patients will then be randomised in a 1:1 ratio between the experimental arm (MM-398), and the control arm (5flurouracil and leucovorin). Therapy will be administered in cycles. Patients will be treated until their disease worsens or unacceptable toxicity occurs. All patients will be followed until death or study closure, whichever occurs first.Pharmacokinetic (PK) Study Blood samples for PK will be collected in Cycle 1 from all patients randomised to MM-398. Additional exploratory analysis may be performed on the PK samples, to help clarify any safety, efficacy or PK issues related to MM-398 that arise during the course of the study.Translational Research This will be conducted in order to address the exploratory objectives of this study. Patients will be required to provide a separate consent for this optional translational research. This phase 3 study will include approximately 270 patients worldwide from sites in North & South America, Europe and Asia.
REC name
Scotland A REC
REC reference
12/SS/0049
Date of REC Opinion
9 May 2012
REC opinion
Further Information Favourable Opinion