Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/18/2016 |
| Start Date: | November 2011 |
| End Date: | October 2015 |
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
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.
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.
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
We found this trial at
24
sites
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