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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merrimack Pharmaceuticals
• Treatments: Camptothecin; Fluorouracil; Gemcitabine; Irinotecan; Leucovorin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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