Spots Global Cancer Trial Database for Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
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Trial Identification
Brief Title: Masitinib in Combination With Gemcitabine for Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Official Title: A Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled, 2-parallel Group, Phase III Study to Compare Efficacy and Safety of Masitinib 9 mg/kg/Day in Combination With Gemcitabine Compared to Placebo in Combination With Gemcitabine in Treatment of Patients With Advanced/Metastatic Pancreatic Cancer
Study ID: NCT00789633
Conditions
Study Description
Brief Summary: The objective of this study is to compare the efficacy and safety of masitinib in combination with gemcitabine to placebo in combination with gemcitabine in patients with advanced/metastatic pancreatic cancer.
Detailed Description: Human pancreatic cancer overexpresses a number of important tyrosine kinase (TK) growth factors receptors and ligands, including expression of both PDGF and PDGF receptors. Drugs that can selectively inhibit TKs are likely to be of benefit in pancreatic cancer. Masitinib is a TK inhibitor, selectively and effectively inhibiting c-Kit (mast cell growth factor receptor), PDGF receptor, FGF receptor and to a lower extent the FAK kinases. Pre-clinical and clinical studies have shown that masitinib can reverse resistance of pancreatic tumor cell lines to gemcitabine. Based on pre-clinical and phase 2 clinical studies, masitinib can be considered as a good candidate to use in combination with gemcitabine in the treatment of pancreatic cancer.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Eastern Connecticut Hematology and Oncology (ECHO), Norwich, Connecticut, United States
MD Anderson, Orlando, Florida, United States
The Emory Clinic, Atlanta, Georgia, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Medical & Surgical Specialists, Galesburg, Illinois, United States
Berkshire Hematology Oncology, Pittsfield, Massachusetts, United States
Henry Ford Health System, Detroit, Michigan, United States
Metro MN CCOP, Saint Louis Park, Minnesota, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
The Valley Hospital, Paramus, New Jersey, United States
Southeastern Medical Oncology Center, Goldsboro, North Carolina, United States
Oregon Health & Science University, Portland, Oregon, United States
Teaching Hospital Brno-Bohunice, Brno, , Czechia
Hospital Chomutov, Chomutov, , Czechia
Oncology Surgery, Kutn谩 Hora, , Czechia
Department of Oncology Teaching Hospital Olomouc, Olomouc, , Czechia
Teaching Hospital Kr谩lovsk茅, Prague 10, , Czechia
Teaching Hospital Na Bulovce, Prague 8, , Czechia
Hospital na Homolce, Prague, , Czechia
CHU Amiens, Amiens, , France
H么pital Priv茅 d'Antony, Antony, , France
Institut Sainte-Catherine, Avignon, , France
H么pital Jean Minjoz, Besan莽on, , France
H么pital Saint-Andr茅, Bordeaux, , France
CHU de la Cavale Blanche, Brest, , France
CHU de Caen, Caen, , France
CHU H么tel Dieu, Clermont-Ferrand, , France
Groupement Hospitalier Universitaire Nord - Beaujon, Clichy, , France
CHU Henri Mondor, Cr茅teil, , France
CHU Henri Mondor, Cr茅teil, , France
H么pital Victor Jousselin, Dreux, , France
Centre Gastro-Loire, Gien, , France
Institut Daniel Hollard, Grenoble, , France
CHD Les Oudairies, La Roche sur Yon, , France
H么pital Andr茅 Mignot, Le Chesnay, , France
H么pital Robert Boulin, Libourne, , France
H么pital Claude Huriez, Lille, , France
Centre Hospitalier de Longjumeau, Longjumeau, , France
H么pital Priv茅 Jean Mermoz, Lyon, , France
H么pital Edouard Herriot, Lyon, , France
Centre L茅on B茅rard, Lyon, , France
Assistance Publique des H么pitaux de Marseille, Marseille, , France
H么pital Saint Joseph, Marseille, , France
Centre Hospitalier Belfort - Montb茅liard, Montbeliard, , France
CHU H么tel Dieu, Nantes, , France
Centre Catherine de Sienne, Nantes, , France
H么pital de la Source, Orl茅ans, , France
Groupe Hospitalier Diaconesse Croix Saint Simon, Paris, , France
H么pital Tenon, Paris, , France
H么pital H么tel Dieu, Paris, , France
H么pital Saint-Joseph, Paris, , France
Polyclinique Francheville, Perigueux, , France
H么pital Haut-L茅v锚que, Pessac, , France
H么pital Hautepierre, Strasbourg, , France
CHU Brabois, Vandoeuvre l猫s Nancy, , France
H么pital Paul Brousse, Villejuif, , France
Hotel Dieu de France, Beirut, , Lebanon
Makassed General Hospital Tarik Jadide, Beirut, , Lebanon
Rafik Hariri University Hospital, Beirut, , Lebanon
Saint Georges Hospital UMC, Beirut, , Lebanon
Middle East Institute of Health- Bsaleem, Metn, , Lebanon
Saint Joseph Hospital Baouchrieh, Metn, , Lebanon
Hammoud Hospital University Medical Center, Saida, , Lebanon
Municipal Clinical Hospital, Arad, , Romania
County Hospital, Baia-Mare, , Romania
Emergency Clinical Hospital, Constanta, , Romania
Pelica Impex SRL Hospital, Pelica Impex, , Romania
County Hospital, Satu Mare, , Romania
Contact Details
Name: Ga毛l Deplanque, MD
Affiliation: H么pital Saint Joseph, Paris, France
Role: PRINCIPAL_INVESTIGATOR
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