Status:
COMPLETED
Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
Lead Sponsor:
Merrimack Pharmaceuticals
Conditions:
Metastatic Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ca...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT01494506
Start Date
November 1 2011
End Date
October 1 2015
Last Update
June 17 2016
Active Locations (79)
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1
Gilbert, Arizona, United States
2
Glendale, Arizona, United States
3
Scottsdale, Arizona, United States
4
Burbank, California, United States