Spots Global Cancer Trial Database for A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: A Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 2 Study of MM-141 Plus Nab-paclitaxel and Gemcitabine Versus Nab-paclitaxel and Gemcitabine in Front-line Metastatic Pancreatic Cancer
Study ID: NCT02399137
Conditions
Study Description
Brief Summary: The purpose of this study is to determine whether the combination of MM-141 plus nab-paclitaxel and gemcitabine is more effective than nab-paclitaxel and gemcitabine alone based on Progression Free Survival (PFS) in front-line metastatic pancreatic cancer patients with high serum levels of free IGF-1.
Detailed Description: This is a randomized, double-blind, placebo-controlled Phase 2 study of MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine in front-line metastatic pancreatic cancer. All patients will be initially screened for free IGF-1 status. Eligible patients with high free IGF-1 will be randomized to receive MM-141 plus nab-paclitaxel and gemcitabine or placebo plus nab-paclitaxel and gemcitabine and patients. Patients with low free IGF-1 or patients who have high free IGF-1 but are not otherwise eligible will be followed in an observational group.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Banner MD Anderson Cancer Ctr., Gilbert, Arizona, United States
Pacific Cancer Medical Center, Inc., Anaheim, California, United States
St. Jude Heritage Healthcare, Fullerton, California, United States
UCLA School of Medicine, Los Angeles, California, United States
Cancer Care Assoc Med Grp, Redondo Beach, California, United States
UCSF Cancer Center, San Francisco, California, United States
Sansum Clinic, Santa Barbara, California, United States
Central Coast Med Onc Corp, Santa Maria, California, United States
Rocky Mountain Cancer Centers, Aurora, Colorado, United States
Baptist Health Med Gr Onc, LLC, Miami, Florida, United States
Florida Cancer AffiliatesOcala, Ocala, Florida, United States
Memorial Regional Hospital, Pembroke Pines, Florida, United States
Cancer Treatment Centers of America-Georgia, Newnan, Georgia, United States
Northwestern University, Chicago, Illinois, United States
University of Illinois at Chicago, Chicago, Illinois, United States
Illinois Cancer Specialists, Chicago, Illinois, United States
Oncology Specialists, S.C., Park Ridge, Illinois, United States
Midwest Regional Medical Cntr, Zion, Illinois, United States
Nylen Cancer Center, Sioux City, Iowa, United States
Cancer Center of Acadiana Research Department, Lafayette, Louisiana, United States
Reliant Medical Group, Inc., Worcester, Massachusetts, United States
Compr Cancer Centers of Nevada, Henderson, Nevada, United States
New York Oncology HematologyPC, Albany, New York, United States
Roswell Park Cancer Inst, Buffalo, New York, United States
Bassett Cancer Institute, Cooperstown, New York, United States
North Shore Hematology Oncology Associates, PC, East Setauket, New York, United States
Columbia University Medical Center, New York, New York, United States
Columbia University, New York, New York, United States
Mid Ohio Onco/ Zangmeister Ctr, Columbus, Ohio, United States
Tulsa Cancer Institute, PLLC, Tulsa, Oklahoma, United States
St. Luke's University Health Network, Bethlehem, Pennsylvania, United States
Fox Chase Cancer Center, Philadelphia, Pennsylvania, United States
Allegheny Cancer Center, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Ctr, Nashville, Tennessee, United States
SCRI - Tennessee Oncology, Nashville, Tennessee, United States
Texas Oncology-Austin Midtown, Austin, Texas, United States
Texas Oncology P A Bedford, Bedford, Texas, United States
Texas Oncology-Dallas P.H., Dallas, Texas, United States
Brooke Army Medical Center (BAMC), Fort Sam Houston, Texas, United States
Texas Oncology-Paris, Paris, Texas, United States
Texas Oncology-Plano East, Plano, Texas, United States
Texas Oncology SA Medical Ctr, San Antonio, Texas, United States
Texas Oncology-Tyler, Tyler, Texas, United States
Virginia Cancer Specialists PC, Fairfax, Virginia, United States
Onc and Hem Asso of SW VA Inc, Salem, Virginia, United States
Cancer Care Northwest, P.S., Spokane Valley, Washington, United States
Northwest Cancer SpecialistsPC, Vancouver, Washington, United States
Cross Cancer Institute, Edmonton, Alberta, Canada
Klinikum rechts der Isar - TUM, Munchen, Bayern, Germany
Universitaetsklinikum Koeln, Koeln, Nordrhein Westfalen, Germany
Caritasklinik St. Theresia, Saarbruecken, Saarland, Germany
Vivantes Klinikum Neukoelln, Berlin, , Germany
Charite Universitaetsmd Berlin, Berlin, , Germany
Uniwersyteckie Centrum Kliniczne, Gdansk, , Poland
WSZ im. L. Rydygiera wToruniu, Torun, , Poland
Hospital Universitario Marques de Valdecilla, Santander, Cantabria, Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Centro Integral Oncologico Clara Campal, Madrid, , Spain
Hospital U de Fuenlabrada, Madrid, , Spain
Hospital Clinico Universitario de Valencia, Valencia, , Spain
Guy's Hospital, London, Greater London, United Kingdom
Sarah Cannon Research Institute UK, London, Greater London, United Kingdom
The Christie, Manchester, Greater Manchester, United Kingdom
Royal Marsden Hospital, Sutton, Surrey, United Kingdom
Royal Marsden Hospital, Sutton, , United Kingdom
Contact Details
Name: MM-141 Medical Director, MD
Affiliation: Merrimack Pharmaceuticals
Role: STUDY_DIRECTOR
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