NAPOLI-1

A Randomized, Open Label Phase 3 Study of MM-398, with or without 5-Fluorouracil and Leucovorin, versus 5- Fluorouracil and Leucovorin, in Patients with Metastatic Pancreatic Cancer Who have Failed Prior Gemcitabine-based Therapy

 

Primary Objective

To compare overall survival (OS) following treatment with MM-398, with or without 5-fluorouracil plus leucovorin, versus 5-fluorouracil and leucovorin in patients with metastatic pancreatic cancer that have progressed on gemcitabine based therapy.

 

Secondary Objectives

The secondary objectives of this study are: 

  • To compare the following between the experimental and control arms: 

    • Time-to-event efficacy endpoints:

      • Progression-free survival (PFS)

      • Time to treatment failure (TTF)

    • Objective Response Rate (ORR)

    • Tumor marker response of CA 19-9

    • Clinical Benefit Response (CBR) 

    • Patient-reported outcomes (PROs) using the European Organization for Research and Treatment of Cancer (EORTC) quality-of-life core questionnaire (EORTC-QLQ-C30)

  • Safety and adverse event profile

  • To determine the pharmacokinetic properties of MM-398, as a single agent and in combination with 5-FU and leucovorin, in this population

Exploratory Objective:

To explore the biomarkers associated with toxicity and efficacy following treatment with MM-398 and MM-398 plus 5-FU and leucovorin (to be evaluated through the companion protocol for translational research, MM-398-07-03-01.TR).

 

 

Related Content

ClinicalTrials.gov Pancreatic Cancer Action Network MM-398 Pancreatic Cancer