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

Information source: Merrimack Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Metastatic Pancreatic Cancer

Intervention: MM-398 (Drug); 5 Fluorouracil (Drug); Leucovorin (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Merrimack Pharmaceuticals

Official(s) and/or principal investigator(s):
Eliel Bayever, MD, Study Director, Affiliation: Merrimack Pharmaceuticals

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall Survival

Secondary outcome:

Progression Free Survival

Time to treatment failure

Objective response rate

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Buenos Aires, Argentina

Rosario, Argentina

Santa Fe, Argentina

Belo Horizonte, Brazil

Ijui, Brazil

Passo Fundo, Brazil

Porto Alegre, Brazil

Sao Paulo, Brazil

Horovice, Czech Republic

Olomouc, Czech Republic

Prague, Czech Republic

Pribram, Czech Republic

Bordeaux, France

Lille, France

Marseille, France

Berlin, Germany

Jens, Germany

Munich, Germany

Ulm, Germany

Budapest, Hungary

Pecs, Hungary

Szeged, Hungary

Szolnok, Hungary

Szombathely, Hungary

Castellana Grotte, Italy

Genova, Italy

Legnano, Italy

Naples, Italy

Roma, Italy

Hwasun-gun, Korea, Republic of

Seoul, Korea, Republic of

Port Elizabeth, South Africa

Pretoria, South Africa

Western Cape, South Africa

Alicante, Spain

Barcelona, Spain

Madrid, Spain

Santander, Spain

Valencia, Spain

Chiayi, Taiwan

Kaohsiung, Taiwan

Taiching, Taiwan

Tainan, Taiwan

Taipei, Taiwan

Taoyuan, Taiwan

Liverpool, United Kingdom

London, United Kingdom

Manchester, United Kingdom

Sutton, United Kingdom

Gilbert, Arizona, United States

Glendale, Arizona, United States

Scottsdale, Arizona, United States

Burbank, California, United States

Duarte, California, United States

Fresno, California, United States

LaVerne, California, United States

San Luis Obispo, California, United States

Boyton Beach, Florida, United States

Atlanta, Georgia, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Henderson, Nevada, United States

Albuquerque, New Mexico, United States

Westmead, New South Wales, Australia

Buffalo, New York, United States

Columbus, Ohio, United States

Norman, Oklahoma, United States

Montreal, Quebec, Canada

Kurralta Park, South Australia, Australia

Greenville, South Carolina, United States

Bedford, Texas, United States

Dallas, Texas, United States

Tyler, Texas, United States

Boxhill, Victoria, Australia

Heidelberg, Victoria, Australia

Melbourne, Victoria, Australia

Fairfax, Virginia, United States

Norfolk, Virginia, United States

Nedlands, Western Australia, Australia

Additional Information

Starting date: November 2011
Last updated: December 23, 2014

Page last updated: August 23, 2015

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