Study of MM-398 With or Without 5-Fluorouracil and Leucovorin, Versus 5-Fluorouracil and Leucovorin in Patients With Metastatic Pancreatic Cancer (NAPOLI 1)

This study is currently recruiting participants.

Verified April 2013 by Merrimack Pharmaceuticals

Sponsor:

Information provided by (Responsible Party):

Merrimack Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT01494506

First received: December 14, 2011

Last updated: April 30, 2013

Last verified: April 2013

History of Changes

Purpose

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.

Condition	Intervention	Phase
Metastatic Pancreatic Cancer	Drug: MM-398 Drug: 5 Fluorouracil Drug: Leucovorin	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Fluorouracil Folic acid Leucovorin calcium Levoleucovorin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Further study details as provided by Merrimack Pharmaceuticals:

Primary Outcome Measures:

Overall Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Progression Free Survival [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Time to treatment failure [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Objective response rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	405
Study Start Date:	November 2011
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: MM-398 MM-398 Q3W IV	Drug: MM-398 Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W Other Name: PEP02
Active Comparator: 5 Fluorouracil and Leucovorin IV 5 Fluorouracil and Leucovorin IV	Drug: 5 Fluorouracil Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Other Name: 5-FU Drug: Leucovorin Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks Other Name: Folinic Acid
Experimental: MM-398, 5-FU and Leucovorin MM-398, 5-FU and Leucovorin Q2W IV	Drug: MM-398 Arm A: MM-398 120 mg/m2 IV Q3W Arm C: MM-398 80mg/m2 IV Q2W Other Name: PEP02 Drug: 5 Fluorouracil Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks Other Name: 5-FU Drug: Leucovorin Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks Arm C: Leucovorin 400 mg/m2 IV every 2 weeks Other Name: Folinic Acid

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494506

Contacts

Contact: Eliel Bayever, MD

617-441-1000

ebayever@merrimackpharma.com

Show 81 Study Locations

Sponsors and Collaborators

Merrimack Pharmaceuticals

More Information

No publications provided

Responsible Party:	Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT01494506 History of Changes
Other Study ID Numbers:	MM-398-07-03-01
Study First Received:	December 14, 2011
Last Updated:	April 30, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Merrimack Pharmaceuticals:

Pancreatic cancer
MM-398
PEP02
Metastatic pancreatic cancer

Gemcitabine refractory pancreatic cancer
Second line pancreatic cancer treatment
Pancreatic cancer post gemcitabine therapy

Additional relevant MeSH terms:

Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Fluorouracil
Gemcitabine
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013

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