NCT01494506

Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 417 (actual)
• Sponsor: Merrimack Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is an open label, randomized phase 3 study of MM-398 with or without 5-Fluorouracil (5-FU) and Leucovorin (also known as folinic acid), versus 5-FU and leucovorin in metastatic pancreatic cancer patients who have progressed on prior gemcitabine based therapy.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	MM-398	Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W
DRUG	5 Fluorouracil	Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks
DRUG	Leucovorin	Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks

Timeline

• Start date: 2011-11-01
• Primary completion: 2014-02-01
• Completion: 2015-10-01
• First posted: 2011-12-19
• Last updated: 2016-06-17
• Results posted: 2016-02-12

Locations

79 sites across 15 countries: United States, Argentina, Australia, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, South Africa, South Korea, Spain, Taiwan, United Kingdom