Spots Global Cancer Trial Database for Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
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Trial Identification
Brief Title: Study of Irinotecan Liposome Injection (ONIVYDE®) in Patients With Small Cell Lung Cancer
Official Title: RESILIENT: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) Versus Topotecan in Patients With Small Cell Lung Cancer Who Have Progressed on or After Platinum-based First-Line Therapy
Study ID: NCT03088813
Conditions
Study Description
Brief Summary: A randomized, open label phase 3 study of irinotecan liposome injection (ONIVYDE®) versus topotecan in patients with small cell lung cancer who have progressed on or after platinum-based first-line therapy The study was conducted in two parts: 1. Dose determination of irinotecan liposome injection 2. A randomized, efficacy study of irinotecan liposome injection versus topotecan
Detailed Description: The study was conducted in two parts: Part 1: Open-label dose-finding study of irinotecan liposome injection. 30 patients were planned to be enrolled. Part 1 Primary Objectives: * Describe the safety and tolerability of irinotecan liposome injection monotherapy administered every 2 weeks * Determine the optimal irinotecan liposome injection monotherapy dose for Part 2 of this study Part 2: A randomized, efficacy study of irinotecan liposome injection versus intravenous (IV) topotecan. Approximately 450 patients were planned to be enrolled in part 2. Part 2 objectives: To compare overall survival following treatment with irinotecan liposome injection with overall survival following treatment with IV topotecan.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
National Jewish Health, Denver, Colorado, United States
Rocky Mountain Cancer Centers, Denver, Colorado, United States
Florida Cancer Specialists (South Region), Fort Myers, Florida, United States
Florida Cancer Specialists, Saint Petersburg, Florida, United States
Northwest Georgia Oncology Centers, Marietta, Georgia, United States
Cancer Treatment Centers of America-Georgia, Newnan, Georgia, United States
Illinois Cancer Care, PC, Peoria, Illinois, United States
Southern Maine Health Care, Biddeford, Maine, United States
University of Maryland Medical Group, Baltimore, Maryland, United States
Henry Ford Hospital, Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan, Grand Rapids, Michigan, United States
Sparrow Regional Cancer Center, Lansing, Michigan, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
North Shore Hematology Oncology Associates, PC, East Setauket, New York, United States
Case Western Reserve University, Cleveland, Ohio, United States
Tri County Hematology & Oncology Associates, Inc, Massillon, Ohio, United States
University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States
Charleston Hematology Oncology Associates, PA, Charleston, South Carolina, United States
Greenville Hospital System University Medical Center, Greenville, South Carolina, United States
Tennessee Oncology, Nashville, Tennessee, United States
MultiCare Health System Institute for Research and Innovation, Spokane, Washington, United States
Summit Cancer Treatment Center, Spokane, Washington, United States
Border Medical Oncology Research Unit, Albury, New South Wales, Australia
South West Healthcare, Warrnambool, Victoria, Australia
Southern Medical Day Care Centre, Wollongong, , Australia
Princess Alexandra Hospital, Woolloongabba, , Australia
AZ Klina, Brasschaat, , Belgium
UZ Leuven, Leuven, , Belgium
Centre Hospitalier de l'Ardenne, Libramont, , Belgium
AZ Sint-Maarten, Mechelen, , Belgium
Hospital de Cancer de Barretos, Fundacoa Pio X II, Barretos, , Brazil
Hospital de Caridade de Ijuí, Ijuí, , Brazil
Oncobio Servicos de Saude, Nova Lima, , Brazil
HGB - Hospital Giovanni Battista - Mãe de Deus Center, Porto Alegre, , Brazil
Hospital Nossa Senhora da Conceição, Porto Alegre, , Brazil
INCA - Instituto Nacional de Câncer, Rio De Janeiro, , Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia, Santo André, , Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José Do Rio Preto, , Brazil
Beijing Cancer Hospital, Beijing, , China
The First Affiliated Hospital of Bengbu Medical College, Bengbu, , China
The First Hospital of Jilin University, Changchun, , China
West China Hospital, Sichuan University, Chengdu, , China
Guangdong Provincial People's Hospital, Guangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Tongji Hospital, Hubei, , China
Linyi Cancer Hospital, Linyi, , China
Henan Cancer Hospital, Zhengzhou, , China
CHU Brest - Hôpital Morvan, Brest, , France
Hôpital Nord - CHU Marseille, Marseille, , France
Institut de Cancérologie de la Loire, Saint-Priest-en-Jarez, , France
Centre Hospitalier de Saint-Quentin, Saint-Quentin, , France
Universitaetsklinikum Freiburg, Freiburg, , Germany
Evangelisches Krankenhaus Hamm GmbH, Hamm, , Germany
Universitaetsklinikum Heidelberg, Heidelberg, , Germany
Pius-Hospital Oldenburg, Oldenburg, , Germany
Semmelweis Egyetem, Budapest, , Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula, , Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, , Hungary
Tudogyogyintezet Torokbalint, Törökbálint, , Hungary
Zala Megyei Szent Rafael Korhaz, Zalaegerszeg, , Hungary
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, , Italy
Azienda Sanitaria Universitaria Integrata di Udine, Udine, , Italy
Chungbuk National University Hospital, Cheongju-si, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, , Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital, Suwon, , Korea, Republic of
KO-MED Centra Kliniczne Biala Podlaska, Biała Podlaska, , Poland
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością, Gdynia, , Poland
SP Zespol Gruzlicy i Chorob Pluc w Olsztynie, Olsztyn, , Poland
Przychodnia Med-Polonia Sp. z o.o., Poznań, , Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego, Poznań, , Poland
S.C Gral Medical S.R.L, Bucuresti, , Romania
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca, Cluj-Napoca, , Romania
S.C Medisprof S.R.L, Cluj-Napoca, , Romania
S.C Centrul de Oncologie Sf. Nectarie S.R.L, Craiova, , Romania
S.C Radiotherapy Center Cluj S.R.L, Floreşti, , Romania
Oncomed SRL, Timişoara, , Romania
SBIH of Arkhangelsk region "Arkhangelsk Clinical Oncological Dispensary", Arkhangel'sk, , Russian Federation
"VitaMed" LLC, Moscow, , Russian Federation
BHI of Omsk region "Clinical Oncology Dispensary", Omsk, , Russian Federation
SBHI of Kaluga Region "Kaluga regional clinical oncology dispensary", Saint Petersburg, , Russian Federation
SPb SBIH "City Clinical Oncological Dispensary", Saint Petersburg, , Russian Federation
SBIH of Yaroslavl region "Regional Clinical Oncological Hospital", Yaroslavl, , Russian Federation
Clinical Center "Bezanijska kosa", Belgrade, , Serbia
Oncomed System, Belgrade, , Serbia
Clinical Center Kragujevac, Belgrad, , Serbia
Institute for Pulmonary Diseases of Vojvodina, Sremska Kamenica, , Serbia
General Hospital Uzice, Užice, , Serbia
ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet De Llobregat, Barcelona, Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital General Universitario Gregorio Marañon, Madrid, , Spain
Hospital Regional Universitario de Malaga, Málaga, , Spain
Hospital Universitario Virgen del Rocio, Sevilla, , Spain
Hospital Universitari i Politecnic La Fe, Valencia, , Spain
Changhua Christian Hospital, Changhua, , Taiwan
Kaohsiung Chang Gung Memorial Hospital, Kaohsiung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Tri-Service General Hospital, Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou, Taoyuan, , Taiwan
Baskent University Adana Application and Research Center, Adana, , Turkey
Trakya University Medical Faculty, Edirne, , Turkey
Istanbul Medeniyet Uni Goztepe Training&Res Hosp, Istanbul, , Turkey
Istanbul University Cerrahpasa - Cerrahpasa Medical Faculty, Istanbul, , Turkey
Inonu Uni. Med. Fac., Malatya, , Turkey
Namik Kemal University, Tekirdağ, , Turkey
CI Chernivtsi RC Oncological Dispensary, Chernivtsi, , Ukraine
CI Dnipropetrovsk CMCH #4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU, Dnipro, , Ukraine
Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv, , Ukraine
Communal Enterprise Kremenchuk Regional Oncology Dispensary of Poltava Regional Council, Kremenchuk, , Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC, Kryvyi Rih, , Ukraine
Treatment-Prevention Institution Volyn Regional Oncological Dispensary, Luts'k, , Ukraine
Odesa Regional Oncologic Dispensary, Odesa, , Ukraine
RCI Sumy Regional Clinical Oncological Dispensary, Sumy, , Ukraine
CCCH City Oncological Center SHEI Uzhgorod NU, Uzhgorod, , Ukraine
Medical Clinic Innovacia, LLC, Vyshhorod, , Ukraine
Contact Details
Name: Ipsen Medical Director
Affiliation: Ipsen
Role: STUDY_DIRECTOR
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