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Brief Title: Study Evaluating Efficacy and Safety of FFX Versus Combination of CPI-613 With mFFX in Patients With Metastatic Adenocarcinoma of the Pancreas
Official Title: A Phase III Multicenter Open-label Randomized Trial to Evaluate Efficacy and Safety of Folfirinox (FFX) Versus Combination of CPI-613 With Modified Folfirinox (mFFX) in Patients With Metastatic Adenocarcinoma of the Pancreas
Study ID: NCT03504423
Brief Summary: A prospective, multicenter, open label, randomized phase III study to evaluate efficacy and safety of FFX versus CPI-613 + mFFX in patients with metastatic adenocarcinoma of the pancreas with age range of 18 to 75 years
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Banner MD Anderson Cancer Center, Gilbert, Arizona, United States
The University of Arizona Cancer Center, Tucson, Arizona, United States
City of Hope, Duarte, California, United States
USC Norris Comprehensive Cancer Center, Los Angeles, California, United States
UCLA Medical Center, Los Angeles, California, United States
Pacific Hematology Oncology Associates, San Francisco, California, United States
Smilow Cancer Hospital at Yale-New Haven, New Haven, Connecticut, United States
Georgetown University Medical Center, Washington, District of Columbia, United States
Mayo Clinic Hospital, Jacksonville, Florida, United States
Mount Sinai Medical Center, Miami Beach, Florida, United States
Northwestern Memorial Hospital - Arkes Family Pavilion, Chicago, Illinois, United States
University of Chicago, Harvey, Illinois, United States
The University of Kansas Cancer Center - Clinical Research Center - Fairway Office Park, Fairway, Kansas, United States
University of Massachusetts Memorial Medical Center, Worcester, Massachusetts, United States
University of Micihgan, Ann Arbor, Michigan, United States
Karmanos cancer Center, Detroit, Michigan, United States
Mayo Clinic Cancer Center (MCCC), Rochester, Minnesota, United States
Washington University, Saint Louis, Missouri, United States
Comprehensive Cancer centers of Nevada, Las Vegas, Nevada, United States
Englewood Hospital and Medical Center, Englewood, New Jersey, United States
Atlantic Health System, Morristown, New Jersey, United States
University of New Mexico Cancer Center, Albuquerque, New Mexico, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
New York University Langone Medical Center, New York, New York, United States
Stony Brook University Hospital, Stony Brook, New York, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Levine cancer Institute, Charlotte, North Carolina, United States
Wake Forest Baptist Health, Winston-Salem, North Carolina, United States
University of Cincinnati Cancer Institute, Cincinnati, Ohio, United States
Cleveland Clinic - Taussig Cancer Center, Cleveland, Ohio, United States
University Hospitals - Seidman Cancer Center, Cleveland, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pittsburgh-Hillman cancer ceter, Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center-Henry-Joyce Cancer Clinic, Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center, Houston, Texas, United States
Huntsman cancer Institute, Salt Lake City, Utah, United States
University of Virginia Cancer Center - Emily Couric Clinical Cancer Center, Charlottesville, Virginia, United States
VCU Massey Cancer Center, Richmond, Virginia, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Seattle Cancer Care Alliance, Seattle, Washington, United States
Hôpital Erasme, Bruxelles, Brussel, Belgium
UZ Leuven, Leuven, VBR, Belgium
CHRU Brest - Hôpital Morvan, Brest, , France
Hôpital Beaujon, Clichy, , France
Centre Hospitalier Départemental Vendée - Hôpital de la Roche-sur-Yon, La Roche-sur-Yon, , France
L'ICM, Institut régional du Cancer de Montpellier, Montpellier, , France
CHU de Nantes - Hôpital Nord Laennec, Nantes Cedex 1, , France
CHU Hopitaux de Bordeaux - Hôpital Saint-André, Pessac, , France
CHU de Poitiers, Poitiers, , France
Centre Eugène Marquis, Rennes, , France
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, , France
Gustave Roussy Cancer Campus Grand Paris (Institut de Cancerologie Gustave-Roussy), Villejuif, , France
SLK-Kliniken Heilbronn GmbH, Heilbronn, BW, Germany
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH, Bochum, , Germany
Universitaetsklinikum Tuebingen, Tuebingen, , Germany
Hillel Yaffe Medical Center, Hadera, Haifa, Israel
Rambam Medical Center, Haifa, , Israel
Shaare Zedek Medical Center, Jerusalem, , Israel
Sanz Medical Center - Laniado Hospital, Netanya, , Israel
The Chaim Sheba Medical Center - Sheba Cancer Research Center (SCRC), Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center, Tel Aviv, , Israel
Assaf-Harofeh Medical Center, Zerifin, , Israel
The Catholic University of Korea - Seoul St. Mary's Hospital (Kangnam St. Mary's Hospital), Seocho, Seoul, Korea, Republic of
Seoul National University Hospital, Busan, , Korea, Republic of
Kyungpook National University Chilgok Hospital, Daegu, , Korea, Republic of
Gachon University Gil Hospital, Incheon, , Korea, Republic of
Inha University Hospital, Incheon, , Korea, Republic of
Seoul National University Bundang Hospital, Seongnam-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Korea University Anam Hospital, Seoul, , Korea, Republic of
Severance Hospital - Yonsei Cancer Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
National Cancer Center, Seoul, , Korea, Republic of
Ajou University Hospital, Suwon, , Korea, Republic of
Name: Philip A Philip, MD, PhD, FRCP
Affiliation: Karmanos Cancer Institute at Wayne State University
Role: PRINCIPAL_INVESTIGATOR