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

Completed · Phase 3

Conditions studied: Metastatic Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01494506

Run by

Merrimack Pharmaceuticals

People needed

417

Starts

2011-11-01

Expected to finish

2015-10-01

Last updated by the study team

2016-06-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed adenocarcinoma of the exocrine pancreas
• Metastatic disease
• Documented disease progression after prior gemcitabine based therapy
• KPS >/= 70
• Adequate bone marrow function
• Adequate hepatic function
• Adequate renal function

You may not qualify if…

• Active CNS metastasis
• Clinically significant GI disorders
• Severe arterial thromboembolic events less than 6 months before inclusion
• NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure
• Active infection or uncontrolled fever
• Pregnant or breast feeding patients

Where it is running

• Study site — Glendale, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• Study site — Burbank, California, United States
• Study site — Duarte, California, United States
• Study site — Fresno, California, United States
• Study site — LaVerne, California, United States
• Study site — San Luis Obispo, California, United States
• Study site — Boyton Beach, Florida, United States
• Study site — Atlanta, Georgia, United States
• Study site — Kansas City, Missouri, United States
• Study site — St Louis, Missouri, United States
• Study site — Henderson, Nevada, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — Buffalo, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Norman, Oklahoma, United States
• Study site — Greenville, South Carolina, United States
• Study site — Bedford, Texas, United States
• Study site — Dallas, Texas, United States
• Study site — Tyler, Texas, United States
• Study site — Fairfax, Virginia, United States
• Study site — Norfolk, Virginia, United States
• Study site — Buenos Aires, Argentina
• Study site — Rosario, Argentina
• Study site — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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