Study of MM-398 With or Without 5-FU/LV, Versus 5-FU/LV in Patients With Metastatic Pancreatic Cancer (NAPOLI-1)

Merrimack Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Leucovorin; Drug: MM-398; Drug: 5 Fluorouracil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01494506

MM-398-07-03-01

Details and patient eligibility

About

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.

Enrollment: 417 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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417 participants in 3 patient groups

MM-398

Experimental group

Description:

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.

Treatment:

Drug: MM-398

5 Fluorouracil and Leucovorin IV

Active Comparator group

Description:

5 Fluorouracil and Leucovorin IV

Treatment:

Drug: 5 Fluorouracil

Drug: Leucovorin

MM-398, 5-FU and Leucovorin

Experimental group

Description:

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.

Treatment:

Drug: 5 Fluorouracil

Drug: MM-398

Drug: Leucovorin