Spots Global Cancer Trial Database for Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
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Trial Identification
Brief Title: Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma
Official Title: A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Study ID: NCT03173560
Conditions
Study Description
Brief Summary: Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective response rate \[ORR\] at 24 weeks \[ORR24W\]) with an improved safety profile compared to lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable Grade 2, or any greater than or equal to (\>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Innovative Clinical Research Institute, LLC, Whittier, California, United States
Baptist Health Medical Group Oncology, LLC - US Oncology, Miami, Florida, United States
Optimal Research, Honolulu, Hawaii, United States
Oklahoma Cancer Specialist and Research Institute , LLC, Tulsa, Oklahoma, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States
University of Tennessee Medical Center, Knoxville, Tennessee, United States
Texas Oncology PA - US Oncology, Fort Worth, Texas, United States
Macquarie University, Macquarie Park, New South Wales, Australia
Northern Cancer Institute, Saint Leonards, Saint Leonards, New South Wales, Australia
Adelaide Cancer Center, Kurralta Park, South Australia, Australia
Sunshine Hospital, Saint Albans, Victoria, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Alberta Health Service - Tom Baker Cancer Centre, Calgary, Alberta, Canada
British Columbia Cancer Agency, Kelowna, British Columbia, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
London Health Sciences Centre, London, Ontario, Canada
Ottawa Hospital Cancer Centre, Ottawa, Ontario, Canada
Sunnybrook Research Institute- University of Toronto, Toronto, Ontario, Canada
Sir Mortimer B Davis Jewish General Hospital, Montreal, Quebec, Canada
Masarykuv onkologicky ustav, Brno, , Czechia
Fakultni nemocnice Olomouc, Olomouc, , Czechia
Fakultni nemocnice v Motole, Prague, , Czechia
Nemocnice Na Bulovce, Prague, , Czechia
Helsingin Yliopistollinen Keskussairaala, Helsinki, , Finland
Tampereen yliopistollinen sairaala, Tampere, , Finland
Turun Yliopistollinen Keskussairaala, Turku, , Finland
Vaasan Keskussairaala, Vaasa, , Finland
Alexandra Hospital, Athens, , Greece
Metropolitan hospital, Athens, , Greece
University General Hospital of Patras, Patras, , Greece
Interbalkan Medical Center of Thessaloniki, Pylaia, , Greece
EUROMEDICA General Clinic of Thessaloniki, Thessaloniki, , Greece
Papageorgiou General Hospital of Thessaloniki, Thessaloniki, , Greece
IRCCS Istituto Nazionale dei Tumori, Milano, Lombardia, Italy
Presidio Ospedaliero San Donato, Arezzo, , Italy
AORN A Cardarelli, Napoli, , Italy
Azienda Ospedaliera San Camillo Forlanini, Roma, , Italy
National Cancer Center, Goyang-si, Gyeonggido, Korea, Republic of
Chonnam National University Hwasun Hospital, Chŏnam, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Severance Hospital - Yonsei University Health System, Seoul, , Korea, Republic of
The Catholic University of Korea, Seoul Saint Mary's Hospital, Seoul, , Korea, Republic of
Hagaziekenhuis, Den Haag, , Netherlands
MC Haaglanden, Den Haag, , Netherlands
Leids Universitair Medisch Centrum, Leiden, , Netherlands
Szpital Specjalistyczny w Brzozowie, Brzozow, , Poland
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk, , Poland
NZOZ Vesalius, Krakow, , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie, Krakow, , Poland
Centrum Onkologii Ziemi Lubelskiej, Lublin, , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii, Opole, , Poland
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Spolka Partnerska, Rzeszow, , Poland
MAGODENT Sp. z o.o. Szpital Elblaska, Warszawa, , Poland
Centro Hospitalar E Universitário de Coimbra EPE, Coimbra, , Portugal
Champalimaud Cancer Center, Lisboa, , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria, Lisbon, , Portugal
Centro Hospitalar do Porto - Hospital de Santo António, Porto, , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe, Porto, , Portugal
Medisprof SRL, Cluj-Napoca, , Romania
Prof Dr I Chiricuta Institute of Oncology, Cluj-Napoca, , Romania
Oncology Center Sfantul Nectarie, Craiova, , Romania
Oncocenter Clinical Oncology, Timisoara, , Romania
Altay Regional Oncology Center, Barnaul, , Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary, Chelyabinsk, , Russian Federation
Central Clinical Hospital With Polyclinic of President Administration of RF, Moscow, , Russian Federation
Moscow City Oncology Hospital #62, Moscow, , Russian Federation
Moscow Scientific Research Oncology Institute P.A. Herzen, Moscow, , Russian Federation
Federal State Institution Medical Radiology Research Center, Obninsk, , Russian Federation
Clinical Oncology Dispensary, Omsk, , Russian Federation
Regional Clinical Oncology Hospital, Yaroslavl, , Russian Federation
Hospital Universitario A Coruna, A Coruna, , Spain
Hospital Universitario Germans Trias i Pujol, Badalona, , Spain
Hospital Clinic de Barcelona, Barcelona, , Spain
Hospital de la Santa Creu I Sant Pau, Barcelona, , Spain
C.H. Regional Reina Sofia, Cordoba, , Spain
ICO l'Hospitalet - Hospital Duran i Reynals, Hospitalet de Llobregat, , Spain
Hospital Clinico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre, Madrid, , Spain
Hospital Universitario Ramon y Cajal, Madrid, , Spain
MD Anderson Cancer Center Madrid, Madrid, , Spain
Hospital Universitario Son Espases, Palma de Mallorca, , Spain
Clinica Universidad Navarra, Pamplona, , Spain
Fundacion Instituto Valenciano de Oncologia, Valencia, , Spain
China Medical University Hospital, Taichung, , Taiwan
Taichung Veterans General Hospital, Taichung, , Taiwan
National Taiwan University Hospital, Taipei, , Taiwan
Taipei Veterans General Hospital, Taipei, , Taiwan
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
Christie Hospital, Manchester, , United Kingdom
Mount Vernon Hospital, Northwood, , United Kingdom
Singleton Hospital, Swansea, , United Kingdom
Contact Details
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