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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merrimack Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01494506
First received: December 14, 2011
Last updated: September 4, 2013
Last verified: September 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Gilbert, Arizona, United States
Glendale, Arizona, United States
Scottsdale, Arizona, United States
United States, California
Burbank, California, United States
Duarte, California, United States
Fresno, California, United States
LaVerne, California, United States
San Luis Obispo, California, United States
United States, Florida
Boyton Beach, Florida, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Missouri
Kansas City, Missouri, United States
St Louis, Missouri, United States
United States, Nevada
Henderson, Nevada, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, New York
Buffalo, New York, United States
United States, Ohio
Columbus, Ohio, United States
United States, Oklahoma
Norman, Oklahoma, United States
United States, South Carolina
Greenville, South Carolina, United States
United States, Texas
Bedford, Texas, United States
Dallas, Texas, United States
Tyler, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Norfolk, Virginia, United States
Argentina
Buenos Aires, Argentina
Rosario, Argentina
Santa Fe, Argentina
Australia, New South Wales
Westmead, New South Wales, Australia
Australia, South Australia
Kurralta Park, South Australia, Australia
Australia, Victoria
Boxhill, Victoria, Australia
Heidelberg, Victoria, Australia
Melbourne, Victoria, Australia
Australia, Western Australia
Nedlands, Western Australia, Australia
Brazil
Belo Horizonte, Brazil
Ijui, Brazil
Passo Fundo, Brazil
Porto Alegre, Brazil
Sao Paulo, Brazil
Canada, Quebec
Montreal, Quebec, Canada
Czech Republic
Horovice, Czech Republic
Olomouc, Czech Republic
Prague, Czech Republic
Pribram, Czech Republic
France
Bordeaux, France
Lille, France
Marseille, France
Germany
Berlin, Germany
Jens, Germany
Munich, Germany
Ulm, Germany
Hungary
Budapest, Hungary
Pecs, Hungary
Szeged, Hungary
Szolnok, Hungary
Szombathely, Hungary
Italy
Castellana Grotte, Italy
Genova, Italy
Legnano, Italy
Naples, Italy
Roma, Italy
Korea, Republic of
Hwasun-gun, Korea, Republic of
Seoul, Korea, Republic of
South Africa
Port Elizabeth, South Africa
Pretoria, South Africa
Western Cape, South Africa
Spain
Alicante, Spain
Barcelona, Spain
Madrid, Spain
Santander, Spain
Valencia, Spain
Taiwan
Chiayi, Taiwan
Kaohsiung, Taiwan
Taiching, Taiwan
Tainan, Taiwan
Taipei, Taiwan
Taoyuan, Taiwan
United Kingdom
Liverpool, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sutton, United Kingdom
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: September 4, 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
Gemcitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on September 18, 2014