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Brief Title: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects With Gastrointestinal, Pancreatic, or Colorectal Cancer
Official Title: RECITE: A Phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy- Induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer
Study ID: NCT03362177
Brief Summary: Study of Romiplostim for Chemotherapy-induced Thrombocytopenia in Adult Subjects with Gastrointestinal, Pancreatic, or Colorectal Cancer
Detailed Description: RECITE: A phase 3 Randomized Placebo-controlled Double-blind Study of Romiplostim for the Treatment of Chemotherapy-induced Thrombocytopenia in Patients Receiving Oxaliplatin-based Chemotherapy for Treatment of Gastrointestinal, Pancreatic, or Colorectal Cancer
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Saint Bernards Medical Center, Jonesboro, Arkansas, United States
Pacific Cancer Medical Center Inc, Anaheim, California, United States
University of California Irvine, Orange, California, United States
Colorado West Healthcare System dba Grand Valley Oncology, Grand Junction, Colorado, United States
Mid Florida Hematology and Oncology Centers PA, Orange City, Florida, United States
Oncology and Hematology Associates of West Broward, PA, Tamarac, Florida, United States
Cleveland Clinic Florida, Weston, Florida, United States
Orchard Healthcare Research Inc, Skokie, Illinois, United States
Christus Saint Frances Cabrini Hospital, Alexandria, Louisiana, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Christus Highland Cancer Treatment Center, Shreveport, Louisiana, United States
Mercy Medical Center, Baltimore, Maryland, United States
American Oncology Partners, PA, Bethesda, Maryland, United States
Massachusetts General Hospital Cancer Center, Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Hattiesburg Clinic Hematology/Oncology, Hattiesburg, Mississippi, United States
Oncology Hematology Associates, Springfield, Missouri, United States
Morristown Medical Center, Morristown, New Jersey, United States
Regional Cancer Care Associates, Sparta, New Jersey, United States
The Center for Cancer and Blood Disorders, Fort Worth, Texas, United States
Medical Oncology Associates PS, Spokane, Washington, United States
Yakima Valley Memorial Hospital, Yakima, Washington, United States
Hospital Universitario Fundacion Favaloro, Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Instituto Oncologico Cordoba, Cordoba, CĂłrdoba, Argentina
Centro de Investigaciones ClĂnicas ClĂnica Viedma, Viedma, RĂo Negro, Argentina
Centro de Diagnostico Investigacion y Tratamiento, Salta, , Argentina
Landeskrankenhaus Steyr, Steyr, , Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien, Wien, , Austria
Instituto de Oncologia do Parana, Curitiba, ParanĂĄ, Brazil
Vencer e Oncoclinica, Teresina, PiauĂ, Brazil
Centro de Pesquisa da Serra Gaucha - Cepesg, Caxias do Sul, Rio Grande Do Sul, Brazil
Catarina Pesquisa Clinica, ItajaĂ, Santa Catarina, Brazil
Loema Instituto de Pesquisa Clinica e Consultores Ltda, Campinas, SĂŁo Paulo, Brazil
Casa de Saude Santa Marcelina, Sao Paulo, SĂŁo Paulo, Brazil
Complex Oncology Center - Ruse EOOD, Ruse, , Bulgaria
Medical Center Nadezhda Clinical EOOD, Sofia, , Bulgaria
Specialized Hospital for Active Treatment of Oncology EAD, Sofia, , Bulgaria
Cape Breton Cancer Centre, Nova Scotia Health Authority, Sydney, Nova Scotia, Canada
Grand River Regional Cancer Centre at Grand River Hospital, Kitchener, Ontario, Canada
Fundacion Colombiana de Cancerologia Clinica Vida, Medellin, Antioquia, Colombia
Oncomedica Imat, Monteria, CĂłrdoba, Colombia
Centro Medico Imbanaco, Cali, Valle Del Cauca, Colombia
Centre Hospitalier Universitaire de Brest, Brest cedex, , France
HĂ´pital EuropĂŠen Georges Pompidou, Paris, , France
Hopital Foch, Suresnes, , France
Institut Gustave Roussy, Villejuif Cedex, , France
General Hospital of Athens Laiko, Athens, , Greece
Aretaieio Hospital, Athens, , Greece
Evgenidio Hospital I Agia Trias, Athens, , Greece
Attikon University Hospital, Athens, , Greece
General Oncology Hospital of Kifissia Agioi Anargyroi, Athens, , Greece
University Hospital of Patras, Patra, , Greece
Agios Loukas Clinic, Thessaloniki, , Greece
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont, Debrecen, , Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz, Gyor, , Hungary
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont Altalanos Orvostudomanyi Kar, Szeged, , Hungary
Azienda Socio Sanitaria Territoriale di Cremona, Cremona, , Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milano, , Italy
Azienda Ospedaliera Citta della Salute e della Scienza di Torino Ospedale Molinette, Torino, , Italy
Oncotech, La Paz, Baja California Sur, Mexico
Centro de Atencion e Investigacion Cardiovascular del Potosi Sc, San Luis Potosi, San Luis PotosĂ, Mexico
Centro Medico Nacional Siglo XXI, Mexico, , Mexico
Oaxaca Site Management Organization SC, Oaxaca, , Mexico
Hospital Goyeneche, Arequipa, , Peru
Oncosalud, Lima, , Peru
Wojewodzki Szpital Specjalistyczny w Bialej Podlaskiej, Biala Podlaska, , Poland
Powiatowe Centrum Zdrowia w Brzezinach Sp Z o o, Brzeziny, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, , Poland
Uniwersytecki Szpital Kliniczny w Poznaniu, Poznan, , Poland
Centro Hospitalar Universitario de Lisboa Norte, EPE - Hospital de Santa Maria, Lisboa, , Portugal
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano, Matosinhos, , Portugal
Centro Hospitalar Universitario do Porto, EPE - Hospital de Santo Antonio, Porto, , Portugal
Centro Hospitalar Universitario de Sao Joao, EPE - Hospital Sao Joao, Porto, , Portugal
Centro Hospitalar Tras-os-Montes e Alto Douro EPE - Unidade de Vila Real, Vila Real, , Portugal
Policlinica de Diagnostic Rapid, Brasov, , Romania
Fundeni Clinical Institute for Digestive Disorders and Liver Transplantation, Bucharest, , Romania
Spitalul Clinic al Cailor Ferate Cluj Napoca, Cluj-Napoca, , Romania
SC Medisprof SRL, Cluj-Napoca, , Romania
Centrul de Oncologie Sf Nectarie SRL, Craiova, , Romania
Institutul Regional de Oncologie Iasi, Iasi, , Romania
SC Oncomed SRL, Timisoara, , Romania
SBHI of Arkhangelsk region Arkhangelsk clinical oncology dispensary, Arkhangelsk, , Russian Federation
Autonomic SHI Republican clinical oncology dispensary of MoH of the Republic of Tatarstan, Kazan, , Russian Federation
Medsi Group, Moscow Region, , Russian Federation
Clinical hospital 2, Group of companies medsi, Moscow, , Russian Federation
LLC Tonus, Nizhniy Novgorod, , Russian Federation
Omsk Regional Clinical Oncology Dispensary, Omsk, , Russian Federation
State budget institution of public health Pyatigorsk oncology dispensary, Pyatigorsk, , Russian Federation
State Institution of Public Health, Ryazan, , Russian Federation
Leningrad Regional Oncology Dispensary na L D Roman, Saint Petersburg, , Russian Federation
FSBI Scientific and Research Oncology Institute named after N N Petrov, Saint-Petersburg, , Russian Federation
State Institution of Public Health Oncology Dispensary 2 of Public Health Krasnodar Region, Sochi, , Russian Federation
State Institution of Public Health Tambov Regional Oncology Dispensary, Tambov, , Russian Federation
Respublican clinical oncology dispensary Minzdrava of Republic of Bashkortostan, Ufa, , Russian Federation
Hospital Clinico Universitario San Cecilio, Granada, AndalucĂa, Spain
Hospital Clinico Universitario de Salamanca, Salamanca, Castilla LeĂłn, Spain
Hospital Universitario Arnau de Vilanova Lleida, Lleida, CataluĂąa, Spain
Hospital Universitari Sant Joan de Reus, Reus, CataluĂąa, Spain
Complexo Hospitalario Universitario de Ourense, Ourense, Galicia, Spain
Hospital Universitario Madrid Sanchinarro, Madrid, , Spain
Baskent Universitesi Adana Doktor Turgut Noyan Uygulama ve Arastirma Merkezi, Adana, , Turkey
Doktor Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara, , Turkey
Hacettepe Universitesi Tip Fakultesi, Ankara, , Turkey
Gazi Universitesi Saglik Arastirma ve Uygulama Merkezi Gazi Hastanesi, Ankara, , Turkey
Ankara Bilkent Sehir Hastanesi, Ankara, , Turkey
Trakya Universitesi Saglik Arastirma ve Uygulama Merkezi, Edirne, , Turkey
Istanbul Universitesi Onkoloji Enstitusu, Istanbul, , Turkey
Prof Dr Cemil Tascioglu Sehir Hastanesi, Istanbul, , Turkey
Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi, Istanbul, , Turkey
Ege Universitesi Tip Fakultesi, Izmir, , Turkey
Izmir Ekonomi Universitesi Medical Point Hastanesi, Izmir, , Turkey
Kocaeli Universitesi Arastirma ve Uygulama Hastanesi, Kocaeli, , Turkey
VM Medical Park Samsun Hastanesi, Samsun, , Turkey
Communal Institution Chernivtsi Regional Clinical Oncological Dispensary, Chernivtsi, , Ukraine
Prykarpatskyy Clinical Oncology Centre, Ivano-Frankivsk, , Ukraine
Transcarpathian Regional Clinical Oncological Dispensary, Uzhgorod, , Ukraine
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR