Trial Condition(s):
Carcinoma, Non-Small-Cell Lung
A 3rd/4th line placebo-controlled trial of sorafenib in patients with predominantly non squamous Non-Small Cell Lung Cancer (NSCLC). (MISSION)
Bayer Identifier:
13266
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
The purpose of the study is to see if sorafenib plus best supportive care (i.e. in addition to the non-cancer treatments patients would normally receive) is an effective treatment for lung cancer compared to best supportive care alone. The safety and tolerability of the two treatment groups will also be compared. The goal of the study is to test the ability of sorafenib to improve survival compared to best supportive care alone.
Inclusion Criteria
- Ability to understand and willingness to sign a written Informed Consent - Advanced relapsed or refractory predominantly non squamous NSCLC. The diagnosis must have been confirmed cyto-/ histologically - Patients must have measurable or non-measurable disease - At least two but not more than three prior standard treatment regimens for NSCLC - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 - Male or female subjects >/= 18 years of age (>/=20 for Japan) at the time of Informed Consent - Life expectancy of at least 12 weeks - Ability to swallow oral medication - Both men and women using adequate barrier birth control measures during the course of the trial and 4 weeks after the completion of trial - Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to start of the study drug: -- Haemoglobin > 9.0 g/dl -- Absolute neutrophil count (ANC) >1,500/mm3 -- Platelet count >/= 100,000/µl -- Total bilirubin </=1.5 x the upper limit of normal -- Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) Aspartate aminotransferase (AST) < 2.5 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) -- Alkaline phosphatase < 4 x upper limit of normal (</= 5 x upper limit of normal in patients with liver metastases) -- Prothrombin Time (PT)-International Normalized Ratio (INR) or Partial Thromboplastin Time (PTT) < 1.5 x upper limit of normal -- Serum creatinine < 1.5 x upper limit of normal -- Calculated creatinine clearance of >/= 50 mL/min
Exclusion Criteria
- NSCLC patients with predominantly squamous cell carcinoma histology Excluded medical conditions: - History of cardiac disease: Congestive heart failure, Active coronary artery disease (CAD), Cardiac arrhythmias (>Grade 2 NCI-CTCAE [National Cancer Institute-Common Terminology Criteria for Adverse Events] vers. 3.0) - Uncontrolled hypertension despite two anti-hypertensive medications - History of Human immunodeficiency virus (HIV) infection or chronic hepatitis B or C - History of organ allograft - Active clinically serious infections (> grade 2 NCI-CTCAE vers. 3.0) - Patients with seizure disorder requiring medication - Patients with evidence or history of bleeding diathesis or coagulopathy - Patients undergoing renal dialysis - Pulmonary hemorrhage/ bleeding event >/= CTCAE grade 2 within four weeks prior to the first dose of the study drug - Any other hemorrhage/ bleeding event >/= CTCAE grade 3 within four weeks prior to the first dose of the study drug - Thrombotic or embolic venous or arterial events such as cerebrovascular accident - Pregnant or breast-feeding women. - Any condition which could affect the absorption or pharmacokinetics of the study drug - Prior treatment with other Vascular Endothelial Growth Factor (VEGF) (R) inhibitors, including compounds that impact vascularity (i.e. sunitinib, thalidomide, vandetanib, vascular disrupting agents [VDA], VEGF-trap and other experimental agents of this class). Only bevacizumab (Avastin) is permitted.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Krankenhaus Grosshansdorf Großhansdorf, Germany, 22927 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Fachkliniken München Gauting Gauting, Germany, 82131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asklepios Klinik Harburg Hamburg, Germany, 21075 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Vincentius-Kliniken gAG Karlsruhe, Germany, 76137 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden NHS Trust (Surrey) Sutton, United Kingdom, SM2 5PT | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Marsden Hospital (London) London, United Kingdom, SW3 6JJ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aberdeen Royal Infirmary Aberdeen, United Kingdom, AB25 2ZN | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Addenbrookes Hospital Cambridge, United Kingdom, CB2 0QQ | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Southmead Hospital Bristol, United Kingdom, BS10 5NB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Highlands Oncology Group Fayetteville, United States, 72703 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Georges Francois Leclerc Dijon DIJON, France, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Croix Rousse LYON CEDEX, France, 69317 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Bretonneau - Tours TOURS, France, 37044 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Stadt Köln - Städt. Krankenhaus Köln-Merheim Köln, Germany, 51109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Thoraxklinik-Heidelberg gGmbH Heidelberg, Germany, 69126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St James' University Hospital Leeds, United Kingdom, LS9 7TF | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Free Hospital London, United Kingdom, NW3 2QG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christie Hospital Greater Manchester, United Kingdom, M20 4BX | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stanford Hospital & Clinics Stanford, United States, 94305 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre René Gauducheau - Nantes SAINT HERBLAIN, France, 44805 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego Szczecin, Poland, 70-891 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Szpital Miejski sw. Aleksandra Kielce, Poland, 25-316 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kinki University Hospital Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kinki-Chuo Chest Medical Center Sakai, Japan, 591-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center Hospital East Kashiwa, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Camillo-Forlanini Roma, Italy, 00151 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Perugia Perugia, Italy, 06156 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Gerardo di Monza Monza, Italy, 20052 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Oscar Lambret Lille, France, 59020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Center Hospitalier Michallon - Grenoble LA TRONCHE, France, 38700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre François Baclesse - CLCC - Caen CAEN, France, 14073 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centrum Onkologii Instytut im. M. Sklodowskiej-Curie Krakow, Poland, 31-115 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Gruzlicy i Chorob Pluc Warszawa, Poland, 01-138 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations NZOZ MRUKMED 2 Sp. p., Przychodnia Specjalistyczna Rzeszow, Poland, 35-021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc Olsztyn, Poland, 10-357 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Teikyo University Hospital Itabashi-ku, Japan, 173-8606 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Cancer Institute Hospital of JFCR Koto-ku, Japan, 135-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hyogo Cancer Center Akashi, Japan, 673-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Kyushu Cancer Center Fukuoka, Japan, 811-1395 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aichi Cancer Center Hospital Nagoya, Japan, 464-8681 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Clinico Humanitas Rozzano, Italy, 20089 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Parma Parma, Italy, 43100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AUSL 06 Livorno - Toscana Livorno, Italy, 57124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. San Luigi Gonzaga Orbassano, Italy, 10043 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. San Giuseppe Moscati Avellino, Italy, 83100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Regional Carlos Haya Málaga, Spain, 29010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario de Zamora Zamora, Spain, 49021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de Cruces Cruces/Barakaldo, Spain, 48903 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital de la Santa Creu i de Sant Pau Barcelona, Spain, 08025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Arnau de Vilanova de Lleida Lleida, Spain, 25198 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hopsital Lucus Agustí Lugo, Spain, 27003 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Isala Klinieken, Locatie Sophia ZWOLLE, Netherlands, 8025 AB | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Skånes Universitetssjukhus Lund, Sweden, 221 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Karolinska Universitetssjukhuset i Solna Stockholm, Sweden, 171 76 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Falu Lasarett Falun, Sweden, 791 82 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Langehoven Drive Oncology Centre Port Elizabeth, South Africa, 6045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Pirjol, Szpak 7 Moodley Durban, South Africa, 4126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Meir Medical Center Kfar Saba, Israel, 4428164 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zrifin, Israel, 6093000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shaare Zedek Medical Center Jerusalem, Israel, 9372212 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Ist Nazionale Tumori GE Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Universitario Virgen del Rocío Sevilla, Spain, 41013 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínic i Provincial de Barcelona Barcelona, Spain, 08036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Complejo Hospitalario de Orense Orense, Spain, 32005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations McGill University Montreal, Canada, H2W 1S6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CU Saint-Luc/UZ St-Luc BRUXELLES - BRUSSEL, Belgium, 1200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis Oost-Limburg GENK, Belgium, 3600 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations ZNA Middelheim ANTWERPEN, Belgium, 2020 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grand Hôpital de Charleroi CHARLEROI, Belgium, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Antonius Ziekenhuis NIEUWEGEIN, Netherlands, 3435 CM | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum Amsterdam, Netherlands, 1081HV | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Atrium Medisch Centrum Parkstad HEERLEN, Netherlands, 6419 PC | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ziekenhuis St. Jansdal HARDERWIJK, Netherlands, 3844 DG | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Elkerliek Ziekenhuis, Lokatie Helmond HELMOND, Netherlands, 5707 HA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hadassah Hebrew University Hospital Ein Kerem Jerusalem, Israel, 9112001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations District Dispensary for Oncology Diseases with Inpatient Plovdiv, Bulgaria | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Interdistrict Dispensary for Oncological Diseases Dr.M.Marko Varna, Bulgaria, 9002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations MHAT Sveta Marina EAD Varna, Bulgaria, 9010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Consultorios Médicos Privados Ramos Mejía, Argentina, B1704ESN | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Privado de Córdoba Córdoba, Argentina, X5016KEH | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenhaus der Elisabethinen Linz Linz, Austria, 4010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pest County Lung Institute Torokbalint, Hungary, 2045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zala Megyei Korhaz Zalaegerszeg, Hungary, 8900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Orszagos Koranyi TBC es Pulmonologiai Intezet Budapest, Hungary, 1529 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital e Maternidade Brasil Santo André, Brazil, 09020 110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Israelita Albert Einstein São Paulo, Brazil, 05651-900 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Irmandade Santa Casa de Misericordia de Porto Alegre Porto Alegre, Brazil, 90050 170 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitetssjukhuset i Linköping Linköping, Sweden, 581 85 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Pretoria, Prinshof Campus Prietoria, South Africa, 0084 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medcial Oncology Centre Rosebank Johannesburg, South Africa, 2196 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Panorama GVI Oncology Cape Town, South Africa, 7500 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rabin Medical Center - Beilinson Campus Petach Tikva, Israel, 4941492 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations District Dispensary for Oncology Diseases with Inpatient Sofia, Bulgaria, 1784 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Specialized Hospital for Active Treatment of Oncology Sofia, Bulgaria | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Especializado ISIS Santa Fé, Argentina, S3000FFV | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Oncológico de Rosario Rosario, Argentina, S2000DSK | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Oncológico Dr. J. M. Urrutia Córdoba, Argentina, 5000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto C.A.I.C.I. Rosario, Argentina, 2000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PALIAR Buenos Aires, Argentina, C1430ERF | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Universität Graz Graz, Austria, 8036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto de Oncologia do Vale São José dos Campos, Brazil, 12245750 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Dispensary Kazan, Russia, 420029 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Oncology Hospital Yaroslavl, Russia, 150054 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Pulmonary Hospital, Tongji University Shanghai, China, 200433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chinese PLA General Hosp. Beijing, China, 100853 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Run Run Shaw Hospital Hangzhou, China, 310016 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Cancer Center DHARMAIS Jakarta, Indonesia, 11420 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Asan Medical Center Seoul, South Korea, 138-736 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul St. Mary's Hospital Seoul, South Korea, 137-701 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10016 | Status Completed | Contact Us: E-mail: [email protected].com Phone: Not Available |
Locations Taichung Veterans General Hospital Taichung, Taiwan, China, 40705 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaohsiung Medical University Hospital Kaohsiung , Taiwan, China, 80756 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Edgardo Rebagliati Martins Lima, Peru, LIMA 11 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Nacional Guillermo Almenara Irigoyen Lima, Peru, LIMA 1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Margaret Hospital Kowloon, Hong Kong, China | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Allgemeines Krankenhaus der Stadt Wien Universitätskliniken Wien, Austria, 1090 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional del Cancer Santiago, Chile, 838-0455 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universidad de Chile Santiago, Chile, 838-0456 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veszprem County Pulmonology Institute Farkasgyepu, Hungary, 8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marmara University Medical Faculty INSTANBUL, Turkey, 34662 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul, Turkey | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Anadolu Saglik Merkezi Kocaeli, Turkey, 41400 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ankara Universitesi Tip Fakultesi Ankara, Turkey | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University General Hospital of Heraklion Heraklion, Greece, 711 10 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sotiria General State Hospital of Chest Diseases Athens, Greece, 11527 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations G. Papanikolaou General Hospital of Thessaloniki Thessaloniki, Greece, 570 10 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Grupo de Assistencia Medica e Prestacao de Servicos Ltda Sao Paulo, Brazil, 01224-010 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Veterans Memorial Medical Center Quezon City, Philippines, 1104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Perpetual Succour Hospital Cebu City, Philippines, 6000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Manila Doctors Hospital Metro Manila, Philippines, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Cancer Institute, Singapore Singapore, Singapore, 119228 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johns Hopkins Singapore IMC Singapore , Singapore, 308433 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Maharaj Nakorn Chiang Mai Hospital Chiang Mai , Thailand, 50200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Hospital Lahore, Pakistan, 54000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations BioCancer Belo Horizonte, Brazil, 30150-281 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Sao Lucas da Pontificia Universidade Catolica do RS Porto Alegre, Brazil, 90610-000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Especializado en Oncología y Hematología Brasilia Brasilia, Brazil, 70680-650 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Railways Hospital named after Semashko Moscow, Russia, 129128 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS Moscow, Russia, 115478 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Clinical Oncology Center St. Petersburg, Russia, 198255 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moscow Clinical Oncology Dispensary n. 1 Moscow, Russia, 105 005 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China, 100021 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Guangdong General Hospital Guangzhou, China, 510080 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Chest Hospital, Shanghai Jiaotong University Shanghai, China, 200030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations PLA 81 Hospital Nanjing, China, 210002 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking University Cancer Hospital Beijing, China, 100142 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 307 Hospital of PLA Beijing, China, 100071 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zhejiang Cancer Hospital Hangzhou, China, 310022 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations West China Hospital, Sichuan University Chengdu, China, 610041 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hasan Sadikin Hospital Bandung , Indonesia, 40161 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Korea University Anam Hospital Seoul, South Korea, 136-705 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Seoul National University Hospital Seoul, South Korea, 110-744 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Samsung Medical Center Seoul, South Korea, 135-710 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Curie Manavata Cancer Centre Mumbai, India, 422004 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeshore Hospital and Research Center Ltd Kerala, India, 682304 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ruby Hall Clinic Pune, India, 411001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chang Gung Memorial Hospital at Linkou Taoyuan, Taiwan, China, 333 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations China Medical University Hospital Taichung, Taiwan, China, 404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica El Golf Lima, Peru, LIMA 27 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Alberto Sabogal Sologuren Callao, Peru, CALLAO 2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncosalud San Borja, Peru | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Wales Hospital Shatin, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Mary Hospital Hongkong, Hong Kong, China | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santo Tomás University Hospital Manila, Philippines, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Siriraj Hospital, Mahidol Bangkok, Thailand, 10700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prince of Songkla University Songkhla, Thailand, 90110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dr Ziauddin Hospital Karachi, Pakistan, 74700 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Hospitalier Départemental-La Roche sur Yon LA ROCHE SUR YON CEDEX, France, 85025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Koch Robert Hospital Edeleny, Hungary, 3780 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Semmelweis Budapest, Hungary, 1125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rittenhouse Hematology/Oncology Philadelphia , United States, 19107 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Zentralklinik Bad Berka GmbH Bad Berka, Germany, 99437 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Innenstadt der Ludwigs-Maximilians-Universität München, Germany, 80336 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Kassel GmbH Kassel, Germany, 34125 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Ulm Ulm, Germany, 89091 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Enfermedades Neoplásicas Lima, Peru, LIMA 34 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase III, multi-center, placebo–controlled trial of Sorafenib (BAY43-9006) in patients with relapsed or refractory advanced predominantly non squamous Non-Small Cell Lung Cancer (NSCLC) after 2 or 3 previous treatment regimens for advanced disease
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Double Blind
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Overall survivalTimeframe: From randomization of the first subject until 36 months later
Secondary Outcome
- Progression-free survivalTimeframe: From randomization of the first subject until 36 months later assessed every 6 weeks
- Disease controlTimeframe: From randomization of the first subject until 36 months later assessed every 6 weeks
- Objective tumor responseTimeframe: From randomization of the first subject until 36 months later assessed every 6 weeks
- Time to progressionTimeframe: From randomization of the first subject until 36 months later assessed every 6 weeks
- Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire for Palliative Care (EORTC QLQ-C15-PAL) - Global Health statusTimeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
- Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13) - coughing subscaleTimeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
- Mean change from baseline in European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire Lung Cancer module (EORTC QLQ-LC13) - dyspneaTimeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
- Mean change from baseline in EuroQol-5D (EQ-5D) - index scoreTimeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
- Mean change from baseline in EuroQol-5D (EQ-5D) - VAS scoreTimeframe: Baseline and up to End of treatment (up to Cycle 41, 21 days per cycle)
Additional Information
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