Sponsor : PharmaMar .
Current Study:
ClinicalTrials.gov Identifier: NCT02566993 .
Study Title:
Clinical Trial of Lurbinectedin (PM01183)/Doxorubicin (DOX) Versus Cyclophosphamide (CTX), Doxorubicin (DOX) and Vincristine (VCR) (CAV) or Topotecan as Treatment in Patients With Small-Cell Lung Cancer (ATLANTIS).
First Received: September 24, 2015 .
Last Updated: February 8, 2017 .
Estimated Enrollment: 600
Study Start Date: July 2016
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure) ,
Locations
| United States, Alabama | |
| Alabama Oncology | |
| Birmingham, Alabama, United States, 35243 | |
| Principal Investigator: Kevin S. Windsor, MD | |
| United States, Arizona | |
| Ironwood Physicians P.C. dba Ironwood Cancer & Research Centers | |
| Chandler, Arizona, United States, 85224 | |
| Principal Investigator: Sujith Kalmadi, MD | |
| United States, California | |
| St Jude Hospital Yorba Linda dba St Joseph Heritage Healthcare | |
| Fullerton, California, United States, 92835 | |
| Principal Investigator: William Lawler, MD | |
| Innovative Clinical Research Institute (ICRI) | |
| Whittier, California, United States, 90603 | |
| Principal Investigator: Daniel Huang, MD | |
| United States, Florida | |
| Boca Raton Regional Hospital Lynn Cancer Institute | |
| Boca Raton, Florida, United States, 33486 | |
| Principal Investigator: Edgardo Santos, MD | |
| Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center | |
| Fort Lauderdale, Florida, United States, 33308 | |
| Principal Investigator: David Z. Drew, MD | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| Principal Investigator: Alberto Chiappori, MD | |
| United States, Illinois | |
| Joliet Oncology-Hematology Associates, Ltd. | |
| Joliet, Illinois, United States, 604 | |
| Principal Investigator: Jason Jung-Gon Suh, MD | |
| Healthcare Research Network III, LLC | |
| Tinley Park, Illinois, United States, 60487 | |
| Principal Investigator: Subramanya S. Rao, MD | |
| United States, Kentucky | |
| Norton Cancer Institute | |
| Louisville, Kentucky, United States, 40202 | |
| Principal Investigator: John T. Hamm, MD | |
| Montgomery Cancer Center | |
| Mount Sterling, Kentucky, United States, 40353 | |
| Principal Investigator: Muhammad-Ali Zaydan, MD | |
| United States, Maryland | |
| Anne Arundel Medical Center Oncology and Hematology | |
| Annapolis, Maryland, United States, 21401 | |
| Principal Investigator: Peter Graze, MD | |
| United States, Michigan | |
| QUEST Research Institute | |
| Royal Oak, Michigan, United States, 48073 | |
| Principal Investigator: Padmaja Vani Venuturumilli, MD | |
| United States, New Jersey | |
| Carol G Simon Cancer Center | |
| Morristown, New Jersey, United States, 07962 | |
| Principal Investigator: Sarada Gurubhagavatula, MD | |
| United States, North Carolina | |
| FirstHealth Outpatient Cancer Center | |
| Pinehurst, North Carolina, United States, 28374 | |
| Principal Investigator: Charles S. Kuzma, MD | |
| United States, Ohio | |
| Gabrail Cancer Center Research | |
| Canton, Ohio, United States, 44718 | |
| Principal Investigator: Nashat Y Gabrail, MD | |
| United States, Oklahoma | |
| Oklahoma Cancer Specialists and Research Institute, LLC | |
| Tulsa, Oklahoma, United States, 74146 | |
| Principal Investigator: Steven C. Buck, DO | |
| United States, Pennsylvania | |
| Associates in Hematology and Oncology, P.C. | |
| Upland, Pennsylvania, United States, 19013 | |
| Principal Investigator: Raymond J. Vivacqua, MD | |
| United States, Texas | |
| Tyler Hematology-Oncology PA | |
| Tyler, Texas, United States, 75701 | |
| Principal Investigator: Arielle S. Lee, MD | |
| United States, Washington | |
| Medical Oncology Associates PS (dba Summit Cancer Centers) | |
| Spokane, Washington, United States, 99208 | |
| Principal Investigator: Arvind Chaudhry, MD, PhD | |
| MultiCare Institute for Research & Innovation | |
| Tacoma, Washington, United States, 98405 | |
| Principal Investigator: Michael A. Harris, MD | |
| United States, Wisconsin | |
| Froedtert Hospital & the Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Principal Investigator: Smitha P. Menon, MD | |
| Austria | |
| Universitätsklinik für Innere Medizin III der PMU | |
| Salzburg, Austria, 5020 | |
| Principal Investigator: Richard Franz Greil, Univ Prof Dr | |
| Belgium | |
| AZ Maria Middelares | |
| Gent, Belgium, 9000 | |
| Principal Investigator: Paul Germonpré, MD | |
| Clinique André Renard | |
| Herstal, Belgium, 4040 | |
| Principal Investigator: Léon Lionel Bosquee, MD | |
| CHR de la citadelle | |
| Liege, Belgium, 4000 | |
| Principal Investigator: Frédérique Bustin, MD | |
| CHU de Liege - Sart Tilman | |
| Liege, Belgium, 4000 | |
| Principal Investigator: Maryam Bourhaba, MD | |
| CHU Ambroise Paré | |
| Mons, Belgium, 7000 | |
| Principal Investigator: Stéphane Holbrechts, MD | |
| Brazil | |
| Nucleo de Oncologia da Bahia | |
| Salvador, BA, Brazil, 40170-110 | |
| Principal Investigator: Clarissa Maria de Cerqueira Mathias, MD | |
| lOP- Instituto de oncologia do paraná | |
| Curitiba, Paraná, Brazil, 80530-010 | |
| Principal Investigator: Fabricio A. Martinelli de Oliveira, MD | |
| Associação Hospital de Caridade de Ijuí | |
| Ijui, RS, Brazil, 98700-000 | |
| Principal Investigator: Fabio A. Franke, MD | |
| Hospital São Lucas da PUCRS | |
| Porto Alegre, RS, Brazil, 90610-000 | |
| Principal Investigator: Carlos H. Escosteguy Barrios, MD | |
| Fundação PlO XII - Hospital de Câncer de Barretos | |
| Barretos, São Paulo, Brazil, 14784-400 | |
| Principal Investigator: Josiane Mourão Dias, MD | |
| lnstituto de Ensino e Pesquisa Säo Lucas - IEP Säo Lucas | |
| Sao Paulo, São Paulo, Brazil, 01236-030 | |
| Principal Investigator: Lucas Vleira dos Santos, MD | |
| Bulgaria | |
| Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte | |
| Panagyurishte, Bulgaria, 4500 | |
| Principal Investigator: Rossitza Krasteva, MD | |
| Multiprofile Hospital for Active Treatment of Women Health - "Nadezhda", Sofia; Clinic of Medical Oncology | |
| Sofia, Bulgaria, 1330 | |
| Principal Investigator: Constanta Timcheva, Prof | |
| University Multiprofile Hospital for Active Treatment "Sv. Ivan Rilski", Sofia | |
| Sofia, Bulgaria, 1431 | |
| Principal Investigator: Bozhil Robev, MD | |
| Canada, Ontario | |
| Southlake Regional Health Centre - Stronach Regional Cancer Centre | |
| Newmarket, Ontario, Canada, L3Y 2P9 | |
| Principal Investigator: Amira Rana, MD | |
| R.S. Mc Laughlin Durham Regional Cancer Centre, Lakeridge Health | |
| Oshawa, Ontario, Canada, L1G 2B9 | |
| Principal Investigator: Gregory Lo, MD | |
| Canada, Quebec | |
| Centre intégré de santé et de services sociaux de la Montérégie Centre | |
| Greenfield Park, Quebec, Canada, J4V 2H1 | |
| Principal Investigator: Giovanna Speranza, MD | |
| Recherche GCP Research | |
| Montreal, Quebec, Canada, H1M 1B1 | |
| Principal Investigator: Michael Palumbo, MD | |
| Czech Republic | |
| Vitkovicka nemocnice, a.s., Plicni oddeleni | |
| Ostrava, Czech Republic, 703 84 | |
| Principal Investigator: Jaromir Roubec, MD | |
| Krajska zdravotni a.s. Masarykova nemocnice o.z. | |
| Usti nad Labem, Czech Republic, 401 13 | |
| Principal Investigator: Pavel Reiterer, MD | |
| Germany | |
| St. Vincentius-Kliniken, Karlsruhe | |
| Karlsruhe, Germany, 76137 | |
| Principal Investigator: Jörg Mezger, Prof. Dr. med. | |
| Onkologische Schwerpunktpraxis Leer-Emden | |
| Leer, Germany, 26789 | |
| Principal Investigator: Lothar Müller, Dr. med. | |
| Medizinische Klinik I | |
| Wuppertal, Germany, 42283 | |
| Principal Investigator: Oliver Schmalz, Dr. med. | |
| Greece | |
| General Hospital of Chest Diseases of Athens "Sotiria" | |
| Athens, Greece, 11527 | |
| Principal Investigator: Konstantinos Syrigos, Prof | |
| General Oncology Hospital of Kifissia "Agioi Anargiroi", 2nd Internal Medicine-Oncology Clinic | |
| Athens, Greece, 14564 | |
| Principal Investigator: Gerasimos Aravantinos, Dr | |
| General Hospital of Thessaloniki "G. Papanikolaou", Pulmonary Clinic, Aristotle University of Thessaloniki | |
| Thessaloniki, Greece, 57010 | |
| Principal Investigator: Konstantinos Zarogoulidis, Prof | |
| Hungary | |
| Országos Korányi TBC és Pulmonológiai Intézet, 6. Pulmonológia és Bronchologia | |
| Budapest, Hungary, 1121 | |
| Principal Investigator: Andrea Fülöp, Dr | |
| Országos Korányi TBC és Pulmonológiai lntézet, 14. Pulmonológia | |
| Budapest, Hungary, 1121 | |
| Principal Investigator: Ildikó Horváth, Dr | |
| Veszprém Megyei Tüdögyógyintézet, 3. Pulmonológiai Osztály | |
| Farkasgyepu, Hungary, 8582 | |
| Principal Investigator: Balázs Medgyasszay, Dr | |
| Mátrai Gyógyintézet, Bronchológia | |
| Matrahaza, Hungary, 3233 | |
| Principal Investigator: István Albert, Dr | |
| Miskolci Semmelweis Kórház és Egyetemi Oktatókórház, Pulmonológiai Osztály | |
| Miskolc, Hungary, 3529 | |
| Principal Investigator: Eszter Csanky, Dr | |
| Fejér Megyei Szent György Egyetemi Oktató Kórház, I. Pulmonológiai Osztály | |
| Szekesfehervar, Hungary, 8000 | |
| Principal Investigator: Zsolt Pápai-Székely, Dr | |
| Markusovszky Egyetemi Oktatókórház, Pulmonológiai Osztály | |
| Szombathely, Hungary, 9700 | |
| Principal Investigator: Barna Szima, Dr | |
| Szent Borbála Kórház, Pulmonológiai osztály | |
| Tatabanya, Hungary, 2800 | |
| Principal Investigator: Csaba Böcskei, PhD | |
| Zala Megyei Kórház, Pulmonologia | |
| Zalaegerszeg, Hungary, 8900 | |
| Principal Investigator: Tehenes Sandor, Dr. | |
| Italy | |
| Azienda Ospedaliero - Universitaria "Policlinico - Vittorio Emanuele" - Presidio G. Rodolico | |
| Catania, Italy, 95123 | |
| Principal Investigator: Hector Soto Parra, MD | |
| Lebanon | |
| Hotel Dieu de France | |
| Achrafieh, Beirut, Lebanon | |
| Principal Investigator: Joseph Kattan, Dr | |
| Ain Wazein Hospital | |
| `Ain Wzei, El Chouf, Lebanon | |
| Principal Investigator: Jawad Makarem, Dr | |
| American University of Beirut Medical Center | |
| Beirut, Lebanon | |
| Principal Investigator: Arafat Tfayli, Dr | |
| Centre Hospitalier Universitaire Notre Dame de Secours | |
| Jbeil, Lebanon | |
| Principal Investigator: Paul Khoueiry, Dr | |
| Hammoud Hospital University Medical Center | |
| Saida, Lebanon | |
| Principal Investigator: Fadi Farhat, Dr | |
| Portugal | |
| Hospital CUF Porto | |
| Porto, Portugal, 4100-180 | |
| Principal Investigator: Barbara Parente, MD | |
| Instituto Português de Oncologia do Porto Francisco Gentil, EPE | |
| Porto, Portugal, 4200-072 | |
| Principal Investigator: Marta Soares, MD | |
| Spain | |
| Hospital Universitari Germans Trias i Pujol ICO | |
| Badalona, Barcelona, Spain, 08916 | |
| Principal Investigator: Enric Carcereny Costa, Dr | |
| Corporació Sanitaria Parc Taulí-Hospital de Sabadell | |
| Sabadell, Barcelona, Spain, 08208 | |
| Principal Investigator: Yolanda García García, Dr | |
| Hospital Universitario Puerta de Hierro Majadahonda | |
| Majadahonda, Madrid, Spain, 28222 | |
| Principal Investigator: Mariano Provencio Pulla, Dr | |
| Hospital Universitari Vall d' Hebron | |
| Barcelona, Spain, | |
| Principal Investigator: Alejandro Navarro Mendivil, Dr | |
| Hospital Universitario Reina Sofia | |
| Cordoba, Spain, 14004 | |
| Principal Investigator: Isidoro Carlos Barneto Aranda, Dr | |
| MD Anderson Cancer Center Madrid | |
| Madrid, Spain, 28033 | |
| Principal Investigator: Pilar López Criado, Dr | |
| Hospital Universitario Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Principal Investigator: María Eugenia Olmedo García, Dr | |
| Hospital Universitario Clínico San Carlos | |
| Madrid, Spain, 28040 | |
| Principal Investigator: José Luis González Larriba, Dr | |
| Hospital Universitario Fundación Jiménez Díaz | |
| Madrid, Spain, 28040 | |
| Principal Investigator: Manuel Dómine Gómez, Dr | |
| Hospital Universitario 12 de Octubre | |
| Madrid, Spain, 28041 | |
| Principal Investigator: Luis Paz-Ares Rodríguez, Dr | |
| Hospital Regional Universitario de Malaga | |
| Malaga, Spain, 29010 | |
| Principal Investigator: Vanesa Gutierrez Calderón, Dr | |
| Complejo hospitalario regional virgen rocío | |
| Sevilla, Spain, 41013 | |
| Principal Investigator: Amparo Sánchez Gastaldo, Dr. | |
| Hospital General Universitario de Valencia | |
| Valencia, Spain, 46014 | |
| Principal Investigator: Ana Blasco Cordellat, Dr | |
| Hospital Universitario La Fe de Valencia | |
| Valencia, Spain, 46026 | |
| Principal Investigator: Oscar Juan Vidal, Dr | |
| Hospital Universitario Miguel Servet | |
| Zaragoza, Spain, 50009 | |
| Principal Investigator: Angel Artal Cortés, Dr | |
| United Kingdom | |
| University College London Hospitals NHS Foundation Trust | |
| London, United Kingdom, NW1 2PG | |
| Principal Investigator: Martin David Forster, Dr | |
| Sarah Cannon Research Institute UK | |
| London, United Kingdom, W1G 6AD | |
| Principal Investigator: Hendrik-Tobias Arkenau, Dr. | |
Sponsors and Collaborators
PharmaMar