Spots Global Cancer Trial Database for Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
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Trial Identification
Brief Title: Study Comparing Rovalpituzumab Tesirine Versus Topotecan in Subjects With Advanced or Metastatic Small Cell Lung Cancer With High Levels of Delta-like Protein 3 (DLL3) and Who Have First Disease Progression During or Following Front-line Platinum-based Chemotherapy (TAHOE)
Official Title: A Randomized, Open-Label, Multicenter, Phase 3 Study of Rovalpituzumab Tesirine Compared With Topotecan for Subjects With Advanced or Metastatic DLL3high Small Cell Lung Cancer (SCLC) Who Have First Disease Progression During or Following Front-Line Platinum-Based Chemotherapy (TAHOE)
Study ID: NCT03061812
Conditions
Study Description
Brief Summary: The purpose of this randomized, open-label, 2-arm, phase 3 study is to assess the efficacy, safety and tolerability of rovalpituzumab tesirine versus topotecan in participants with advanced or metastatic SCLC with high levels of DLL3, who have first disease progression during or following front-line platinum-based chemotherapy.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Clearview Cancer Institute /ID# 155873, Huntsville, Alabama, United States
Mitchell Cancer Institute /ID# 158151, Mobile, Alabama, United States
Carti /Id# 156982, Little Rock, Arkansas, United States
Highlands Oncology Group /ID# 155902, Springdale, Arkansas, United States
Cedars-Sinai Medical Center /ID# 157102, Beverly Hills, California, United States
Moore UC San Diego Cancer Center /ID# 156965, La Jolla, California, United States
Los Angeles Hematology Oncolog /ID# 155879, Los Angeles, California, United States
University of California, Davis Comprehensive Cancer Center /ID# 157001, Sacramento, California, United States
St Jude Hospital dba St Joseph /ID# 155899, Santa Rosa, California, United States
Icri /Id# 157090, Whittier, California, United States
Christiana Care Health Service /ID# 158171, Newark, Delaware, United States
Cancer Specialists of North Florida - Southpoint /ID# 155828, Jacksonville, Florida, United States
Georgia Cancer Center /ID# 160206, Atlanta, Georgia, United States
St. Luke's Mountain States Tumor Institute - Meridian /ID# 164550, Meridian, Idaho, United States
NorthShore University HealthSystem - Evanston Hospital /ID# 157054, Evanston, Illinois, United States
Ingalls Memorial Hosp /ID# 155871, Harvey, Illinois, United States
Goshen Center for Cancer Care /ID# 155946, Goshen, Indiana, United States
University of Louisville /ID# 155947, Louisville, Kentucky, United States
Ochsner Clinic Foundation /ID# 160807, Baton Rouge, Louisiana, United States
Dana-Farber Cancer Institute /ID# 160210, Boston, Massachusetts, United States
Sparrow Regional Cancer Center, Sparrow Health System /ID# 157021, Lansing, Michigan, United States
Nebraska Hematology Oncology /ID# 155900, Lincoln, Nebraska, United States
Gabrail Cancer Center Research /ID# 155920, Canton, Ohio, United States
Oregon Health and Science University /ID# 157055, Portland, Oregon, United States
UPMC Hillman Cancer Ctr /ID# 164403, Pittsburgh, Pennsylvania, United States
Univ Medical Ctr Brackenridge /ID# 156967, Austin, Texas, United States
UT Southwestern Medical Center /ID# 158150, Dallas, Texas, United States
University of Vermont Medical Center /ID# 162317, Burlington, Vermont, United States
University of Washington /ID# 162626, Seattle, Washington, United States
Medical Oncology Associates /ID# 156856, Spokane, Washington, United States
West Virginia Univ School Med /ID# 155872, Morgantown, West Virginia, United States
Blacktown Hospital /ID# 158907, Blacktown, New South Wales, Australia
St George Hospital /ID# 158855, Kogarah, New South Wales, Australia
Southern Medical Day Care Ctr /ID# 158853, Wollongong, New South Wales, Australia
The Prince Charles Hospital /ID# 158897, Chermside, Queensland, Australia
Ballarat Health Service /ID# 158904, Ballarat, Victoria, Australia
Austin Hospital /ID# 158898, Heidelberg, Victoria, Australia
Bobruysk Interdistrict Onco. /ID# 169394, Bobruisk, , Belarus
State Institution Republican Scientific Practical Center of Oncology and Medica /ID# 159325, Lesnoy, , Belarus
Mogilev Reg. Oncologic dispe /ID# 159326, Mogilev, , Belarus
CHU Saint-Pierre /ID# 159521, Bruxelles, Bruxelles-Capitale, Belgium
Grand Hôpital de Charleroi /ID# 158748, Charleroi, Hainaut, Belgium
Cliniques universitaires Saint /ID# 158751, Brussels, , Belgium
Hopital de Jolimont /ID# 159755, Haine Saint Paul, , Belgium
UZ Leuven /ID# 158752, Leuven, , Belgium
CHU de Liege Sart Tilman /ID# 158753, Liege, , Belgium
CHU Charleroi (Vesale) /ID# 159756, Montigny-le-tilleul, , Belgium
Liga Norte Rio Grandense Cont. /ID# 159015, Natal, Rio Grande Do Norte, Brazil
Associação Hospital Beneficente São Vicente de Paulo - Hospital São Vicente de P /ID# 159668, Passo Fundo, Rio Grande Do Sul, Brazil
Fundacao Pio XII - Hospital de Cancer de Barretos /ID# 159017, Barretos, Sao Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto /ID# 159666, Sao Jose Do Rio Preto, Sao Paulo, Brazil
Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 159665, Rio de Janeiro, , Brazil
UMHAT Tsaritsa Joanna - ISUL /ID# 159641, Sofia, , Bulgaria
UMHAT Sv. Ivan Rilski /ID# 159642, Sofia, , Bulgaria
Cross Cancer Institute /ID# 159519, Edmonton, Alberta, Canada
Juravinski Cancer Clinic /ID# 159514, Hamilton, Ontario, Canada
Hopital du Sacre Coeur Montreal /ID# 159515, Montreal, Quebec, Canada
CHU de Quebec-Universite Laval /ID# 159093, Quebec City, Quebec, Canada
Cisss Du Bas-Saint-Laurent Hopital Regional de Rimouski /Id# 208931, Rimouski, Quebec, Canada
Jilin Cancer Hosptial /ID# 204059, Changchun, Jilin, China
Klinicki bolnicki centar Sestre milosrdnice /ID# 158811, Zagreb, Grad Zagreb, Croatia
Klinika za plucne bolesti Jordanovac /ID# 159502, Zagreb, Grad Zagreb, Croatia
Klinicki bolnicki centar Rijeka /ID# 159501, Rijeka, Primorsko-goranska Zupanija, Croatia
Thomayerova nemocnice /ID# 159061, Prague, Praha 4, Czechia
Nemocnice Na Plesi s.r.o. /ID# 161190, Nová Ves pod Pleší, Pribram, Czechia
Nemocnice Rudolfa a Stefanie /ID# 159652, Benesov, , Czechia
Nemocnice Horovice a.s. /ID# 161191, Horovice, , Czechia
Krajska nemocnice Liberec a.s. /ID# 159653, Liberec, , Czechia
Herlev Hospital /ID# 158049, Herlev, Hovedstaden, Denmark
Odense Universitets Hospital /ID# 158050, Odense C, Syddanmark, Denmark
Rigshospitalet, Finsen Centre /ID# 158051, Copenhagen, , Denmark
Hopital Haut-Lévêque /ID# 160558, Pessac CEDEX, Gironde, France
Assis.Publique-Hopital Nord /ID# 160554, Marseille, Provence-Alpes-Cote-d Azur, France
Centre Leon Berard /ID# 160561, Lyon CEDEX 08, Rhone, France
Centre Hosp Intercommunal de Creteil /ID# 162684, Creteil, Val-de-Marne, France
Assistance Publique- Hopitaux /ID# 160552, Paris, , France
Hospital Pontchaillou /ID# 160555, Rennes, , France
KH Martha-Maria Halle Dolau /ID# 158796, Halle (Saale), Sachsen-Anhalt, Germany
Evangelische Lungenklinik Berl /ID# 159168, Berlin, , Germany
Asklepios Fachkliniken M. Gaut /ID# 158791, Gauting, , Germany
Lungen Clinic Grosshansdorf /ID# 158770, Grosshansdorf, , Germany
Thoraxklinik Heidelberg gGmbH /ID# 159169, Heidelberg, , Germany
Klinikum Kassel /ID# 158788, Kassel, , Germany
Klinik Loewenstein GmbH /ID# 159167, Löwenstein, , Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 159165, Athens, , Greece
Metropolitan Hospital /ID# 159162, Athens, , Greece
University Hospital of Ioannin /ID# 159163, Ioannina, , Greece
Euromedica General Clinic /ID# 159161, Thessaloniki, , Greece
Torokbalinti Tudogyogyintezet /ID# 207053, Budapest, Pest, Hungary
Semmelweis Egyetem /ID# 161197, Budapest, , Hungary
Orszagos Koranyi Pulmonologiai Intezet /ID# 158967, Budapest, , Hungary
Dup_Debreceni Egyetem Klinikai Központ /ID# 161209, Debrecen, , Hungary
Veszprem Megyei Tuedoegyogyint /ID# 162607, Farkasgyepu, , Hungary
Petz Aladar Megyei Oktato Korh /ID# 158978, Gyor, , Hungary
Matrai Gyogyintezet /ID# 158979, Matrahaza, , Hungary
AUSL 8 Arezzo Ospedale San Don /ID# 160967, Arezzo, , Italy
Istituto Europeo di Oncologia /ID# 158942, Milan, , Italy
A.O.U. San Luigi Gonzaga /ID# 158945, Orbassano, , Italy
Ospedale Santa Maria delle Cro /ID# 158940, Ravenna, , Italy
IFO Istituto Nazionale Tumori /ID# 158941, Rome, , Italy
Aichi Cancer Center Hospital /ID# 164975, Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East /ID# 165726, Kashiwa-shi, Chiba, Japan
Kyushu University Hospital /ID# 165723, Fukuoka-shi, Fukuoka, Japan
Kurume University Hospital /ID# 164586, Kurume-shi, Fukuoka, Japan
Hokkaido Cancer Center /ID# 165237, Sapporo-shi, Hokkaido, Japan
Hyogo Cancer Center /ID# 165125, Akashi-shi, Hyogo, Japan
Himeji Medical Center /ID# 165893, Himeji-shi, Hyogo, Japan
Duplicate_Kanazawa University Hospital /ID# 165129, Kanazawa-shi, Ishikawa, Japan
Yokohama City University Hospital /ID# 165748, Yokohama-shi, Kanagawa, Japan
Kanagawa Cardiovascular and Respiratory Center /ID# 164374, Yokohama-shi, Kanagawa, Japan
Sendai Kousei Hospital /ID# 166061, Sendai-shi, Miyagi, Japan
Japanese Red Cross Okayama Hospital /ID# 165156, Okayama-shi, Okayama, Japan
Kansai Medical University Hospital /ID# 165055, Hirakata-shi, Osaka, Japan
Kindai University Hospital /ID# 166394, Osaka-sayama-shi, Osaka, Japan
Osaka City General Hospital /ID# 165717, Osaka-shi, Osaka, Japan
Shizuoka Cancer Center /ID# 166466, Sunto-gun, Shizuoka, Japan
Tokushima University Hospital /ID# 165812, Tokushima-shi, Tokushima, Japan
National Cancer Center Hospital /ID# 166768, Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital Of JFCR /ID# 166249, Koto-ku, Tokyo, Japan
Duplicate_Showa University Hospital /ID# 165574, Shinagawa-ku, Tokyo, Japan
Wakayama Medical University /ID# 166032, Wakayama-shi, Wakayama, Japan
Matsusaka City Hospital /ID# 166126, Matsusaka-shi MIE, , Japan
Kanagawa Cancer Center /ID# 165816, Yokohama, , Japan
Dong-A University Hospital /ID# 159296, Busan, Busan Gwang Yeogsi, Korea, Republic of
CHA Bundang Medical center CHA University /ID# 204416, Seongnam si, Gyeonggido, Korea, Republic of
Chonnam National University Hospital /ID# 159294, Gwangju, Jeonranamdo, Korea, Republic of
Kyungpook National University Chilgok Hospital /ID# 159292, Daegu, Seoul Teugbyeolsi, Korea, Republic of
Yonsei University Health System, Severance Hospital /ID# 159288, Seodaemun-gu, Seoul Teugbyeolsi, Korea, Republic of
Korea University Guro Hospital /ID# 159293, Seoul, Seoul Teugbyeolsi, Korea, Republic of
Chungbuk National University /ID# 159291, Cheongju-si, , Korea, Republic of
Asan Medical Center /ID# 159290, Seoul, , Korea, Republic of
Pauls Stradins Clinical /ID# 158713, Riga, , Latvia
Riga East Clinical University /ID# 158714, Riga, , Latvia
Centro de Investigación Clinica Chapultepec /ID# 161000, Morelia, Michoacan, Mexico
Health Pharma Professional Research S.A de C.V /ID# 160020, Del. Benito Juárez, , Mexico
Universitair Medisch Centrum Groningen /ID# 158088, Groningen, , Netherlands
Ziekenhuis St. Jansdal /ID# 158652, Harderwijk, , Netherlands
Isala /ID# 158653, Zwolle, , Netherlands
Mrukmed. Lekarz Beata Madej Mruk i Partner /ID# 160537, Rzeszów, Podkarpackie, Poland
Copernicus PL Sp. z o. o., WCO /ID# 160538, Gdansk, , Poland
Szpitale Pomorskie Sp. z o.o /ID# 160536, Gdynia, , Poland
Centro Hospitalar Lisboa Norte, EPE /ID# 158687, Lisbon, Lisboa, Portugal
IPO Lisboa FG, EPE /ID# 158995, Lisboa, , Portugal
Hospital da Luz, SA /ID# 158996, Lisbon, , Portugal
Unidade Local Saude Matosinhos /ID# 158682, Matosinhos, , Portugal
Hospital CUF Porto /ID# 158685, Porto, , Portugal
IPO Porto FG, EPE /ID# 158686, Porto, , Portugal
S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 160847, Craiova, Dolj, Romania
Oncocenter Oncologie Clinica S /ID# 160848, Timisoara, Timis, Romania
Spitalul Judetean de Urgenta A /ID# 160846, Alba, , Romania
National Medical Research Cntr /ID# 207436, Moscow, Moskovskaya Oblast, Russian Federation
LLC Novaya Klinika /ID# 205539, Pyatigorsk, Stavropol Skiy Kray, Russian Federation
Arkhangelsk clinical oncology /ID# 159309, Arkhangelsk, , Russian Federation
Kaluga Regional Clinical Oncol /ID# 160179, Kaluga, , Russian Federation
Clinical Onco Dispensary /ID# 159307, Omsk, , Russian Federation
PMI Euromedservice /ID# 159311, Pushkin, , Russian Federation
Smolensk Regional Onc Clin Dis /ID# 159314, Smolensk, , Russian Federation
LLC BioEq Ltd. /ID# 159310, St. Petersburg, , Russian Federation
N.N. Petrov Research Inst Onc /ID# 159312, St. Petersburg, , Russian Federation
Clinical Center of Nis /ID# 160059, NIS, Nisavski Okrug, Serbia
Institut za onkologiju i radio /ID# 160058, Belgrade, , Serbia
Klinicki centar Srbije /ID# 160024, Belgrade, , Serbia
Institute For Pulmonary Diseas /ID# 158813, Sremska Kamenica, , Serbia
National University Hospital /ID# 158802, Singapore, , Singapore
National Cancer Ctr Singapore /ID# 158803, Singapore, , Singapore
Hospital Clinic /ID# 159031, Barcelona, , Spain
Hospital Santa Creu i Sant Pau /ID# 159028, Barcelona, , Spain
Hospital General Universitario Gregorio Maranon /ID# 159025, Madrid, , Spain
Hospital Universitario HM Sanchinarro /ID# 159024, Madrid, , Spain
Hospital Clinico Universitario de Valencia /ID# 159027, Valencia, , Spain
Sahlgrenska US Gbg /ID# 159534, Göteborg, Vastra Gotalands Lan, Sweden
Uppsala University Hospital /ID# 159050, Uppsala, , Sweden
National Cheng Kung University Hospital /ID# 158844, Tainan City, Tainan, Taiwan
National Taiwan University Hospital /ID# 158865, Taipei City, Taipei, Taiwan
Tri-Service General Hospital /ID# 158985, Taipei City, Taipei, Taiwan
Taichung Veterans General Hosp /ID# 158866, Taichung City, , Taiwan
Hacettepe University Medical Faculty /ID# 159238, Altindağ, Ankara, Turkey
Inonu Universitesi Turgut Ozal /ID# 159241, Battalgazi/malatya, , Turkey
Ege University Medical Faculty /ID# 159239, Izmir, , Turkey
Dr. Suat Seren Gogus Has /ID# 159240, Izmir, , Turkey
Ataturk Gogus Hastaliklari ve /ID# 160056, Kecioren/ankara, , Turkey
CI Zaporizhzhia Regional Clinical Oncological Dispensary /ID# 159122, Zaporizhzhia, Zaporizka Oblast, Ukraine
Municipal institution /ID# 159867, Chernivtsi, , Ukraine
Municipal institution Multifie /ID# 159121, Dnipro, , Ukraine
Regional Center of Oncology /ID# 159123, Kharkiv, , Ukraine
PE PMC Acinus, Medical and Diagnostic Center /ID# 159125, Kropyvnytskyi, , Ukraine
ME Kryviy Rih Oncology Dispensary /ID# 159119, Kryviy RIH, , Ukraine
Volyn Regional Medical Oncology Centre /ID# 159124, Lutsk, , Ukraine
Communal Nonprofit Enterprise "Central City Clinical Hospital" of Uzhhorod City /ID# 159868, Uzhhorod, , Ukraine
Guy's and St Thomas' NHS Found /ID# 159581, London, London, City Of, United Kingdom
United Lincolnshire Hospitals /ID# 159579, Boston, , United Kingdom
Charing Cross Hospital /ID# 159582, London, , United Kingdom
Christie NHS Foundation Trust /ID# 159099, Manchester, , United Kingdom
James Cook University Hospital /ID# 159583, Middlesborough, , United Kingdom
Royal Preston Hospital /ID# 159578, Preston, , United Kingdom
Contact Details
Name: AbbVie Inc.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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