Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer (NAPOLI-1)
Metastatic Pancreatic Cancer
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring Pancreatic cancer, MM-398, PEP02, Metastatic pancreatic cancer, Gemcitabine refractory pancreatic cancer, Second line pancreatic cancer treatment, Pancreatic cancer post gemcitabine therapy
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Experimental
MM-398
5 Fluorouracil and Leucovorin IV
MM-398, 5-FU and Leucovorin
MM-398 120 mg/m2 Q3W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 120 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 100 mg/ m2 of irinotecan free base.
5 Fluorouracil and Leucovorin IV
MM-398 80 mg/m2, 5-FU and Leucovorin Q2W IV. Note: The published dose of ONIVYDE was expressed as the irinotecan hydrochloride trihydrate until October 2015. It is now expressed as the irinotecan free base. Converting a dose based on irinotecan hydrochloride trihydrate to a dose based on irinotecan free base is accomplished by substituting the Molecular Weight of irinotecan hydrochloride trihydrate (677.19 g/mole) with the Molecular Weight of irinotecan free base (586.68 g/mole), which results in a conversion factor of 0.866. 80 mg/m2 dose of irinotecan hydrochloride trihydrate is equivalent to 70 mg/ m2 of irinotecan free base.