Trial Condition(s):
Metastatic Colorectal Cancer
Patients with metastatic colorectal cancer treated with regorafenib or placebo after failure of standard therapy
Bayer Identifier:
14387
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
This is a randomized, double-blind, placebo-controlled multi-center phase III study to evaluate efficacy and safety of regorafenib in patients with metastatic colorectal cancer (CRC) who have progressed on/after all approved drugs for CRC
Inclusion Criteria
- Histological or cytological documentation of adenocarcinoma of the colon or rectum - Progression during or within 3 months following the last administration of approved standard therapies. Patients treated with oxaliplatin in an adjuvant setting should have progressed during or within 6 months of completion of adjuvant therapy - Patients with measurable or non measurable disease - Eastern Cooperative Oncology Group (ECOG) Performance Status of </= 1 - Life expectancy of at least 3 months - Adequate bone marrow, liver and renal function
Exclusion Criteria
- Unstable/uncontrolled cardiac disease - History of arterial or venous thrombotic or embolic events - Symptomatic metastatic brain or meningeal tumors - Patients with evidence or history of bleeding diathesis - Interstitial lung disease - Persistent proteinuria >/= grade 3 - Unresolved toxicity > grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity </= Grade 2
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg Halle, Germany, 06120 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Oldenburg GmbH Oldenburg, Germany, 26133 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Rochester Rochester, United States, 55905 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHRU Lille - Cedex LILLE CEDEX, France, 59037 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinique Victor Hugo - Le Mans LE MANS CEDEX 2, France, 72015 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Eugène Marquis - Rennes Cedex RENNES, France, 35042 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. Osp Niguarda Ca' Granda Milano, Italy, 20162 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fondazione Poliambulanza - Istituto Ospedaliero Brescia, Italy, 25124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Seconda Università Napoli, Italy, 80131 | 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 Universitario 12 de Octubre Madrid, Spain, 28041 | 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 Hospital Universitario "La Paz" Madrid, Spain, 28046 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UZ Leuven Gasthuisberg LEUVEN, Belgium, 3000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Onkologische Schwerpunktpraxis Porta Westfalica, Germany, 32457 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marienhospital Stuttgart, Germany, 70199 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations LMU Klinikum der Universität München - Großhadern München, Germany, 81377 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städt. Klinikum München München, Germany, 81737 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HELIOS Klinikum Berlin - Buch Berlin, Germany, 13125 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Schwerpunktpraxis für Hämatologie und Onkologie Magdeburg, Germany, 39104 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Städtische Kliniken München GmbH München, Germany, 81925 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Essen Essen, Germany, 45122 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut du Cancer de Montpellier MONTPELLIER, France, 34298 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Robert Debré - Reims Cedex REIMS , France, 51092 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Pitié-Salpétrière - Paris PARIS, France, 75651 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centre Oscar Lambret - Lille LILLE CEDEX, France, 59020 | Status Active, not recruiting | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital de la Timone - Marseille MARSEILLE, France, 13005 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro Genova, Italy, 16132 | Status Completed | Contact Us: E-mail: [email protected]ealthcare.com Phone: Not Available |
Locations H.-Hartziekenhuis Roeselare ROESELARE, Belgium, 8800 | 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 UZ Antwerpen EDEGEM, Belgium, 2650 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Erasme/Erasmus Ziekenhuis BRUXELLES - BRUSSEL, Belgium, 1070 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni nemocnice Na Bulovce Praha, Czech Republic, 18081 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Masarykuv onkologicky ustav Brno, Czech Republic, 65 653 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Faculty Hospital Hradec Kralove Hradec Kralove, Czech Republic, 500 05 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 5262000 | Status Completed | Contact Us: E-mail: clinical-t[email protected] Phone: Not Available |
Locations Tel-Aviv Sourasky Medical Center Tel Aviv, Israel, 6423906 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kaplan Medical Center Rehovot, Israel, 7610001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Edith Wolfson Medical Center Holon, Israel | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Assaf Harofeh Medical Center Zrifin, Israel, 6093000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Concord Repatriation General Hospital Concord, Australia, 2139 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Princess Alexandra Hospital Woolloogabba, Australia, 4102 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Queen Elizabeth Hospital Woodville South, Australia, 5011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.R.N. Antonio Cardarelli Napoli, Italy, 80131 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. di Modena Policlinico Modena, Italy, 41124 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Pisana Pisa, Italy, 56126 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Università Cattolica del Sacro Cuore Roma, Italy, 00168 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O. di Reggio Emilia Reggio Emilia, Italy, 42100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Istituto Nazionale Tumori Milano, Italy, 20133 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ciutat Sanitària i Universitaria de la Vall d'Hebron Barcelona, Spain, 08035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Corporació Sanitària Parc Taulí Sabadell, Spain, 08208 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico Universitario San Carlos Madrid, Spain, 28040 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Català d'Oncologia Hospitalet de Llobregat, Spain, 08907 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institut Jules Bordet/Jules Bordet Instituut BRUXELLES - BRUSSEL, Belgium, 1000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fakultni Nemocnice Olomouc Olomouc, Czech Republic, 775 20 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Rambam Health Corporation Haifa, Israel, 3109601 | 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 Hospital Santo António Oporto Porto, Portugal, 4099-001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Portugues de Oncologia de Francisco Gentil Porto, Portugal, 4200-072 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Gazi Univ. Medical Faculty Ankara, Turkey, 06500 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Lifecenter Belo Horizonte, Brazil, 30110-090 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Barzilai Medical Center Ashkelon, Israel, 7830604 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Soroka University Medical Center Beer Sheva, Israel, 8410101 | 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 Royal Melbourne Hospital Parkville, Australia, 3050 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Western Hospital Footscray, Australia, 3011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal North Shore Hospital St Leonards, Australia, 2065 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa, Portugal, 1649-035 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Infante Dom Pedro Aveiro , Portugal, 3810-096 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jósa András Oktató Kórház Nyiregyhaza, Hungary, 4400 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Debrecen, Hungary, 4032 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Semmelweis Egyetem AOK Budapest, Hungary, 1082 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Altalanos Orvostudomanyi Kar Szeged, Hungary, 6725 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Univ. Medical Faculty, DETAM Istanbul, Turkey, 34390 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Marmara University Medical Faculty INSTANBUL, Turkey, 34662 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncoclinic Fortaleza, Brazil, 60160-230 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Associação Hospital de Caridade de Ijuí Ijuí, Brazil, 98700-000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinica AMO Salvador, Brazil, 41830-492 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Cantonal Universitaire de Genève Genève, Switzerland, 1211 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kantonsspital Graubünden Chur, Switzerland, 7000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Krankenanstalt Mutterhaus der Borromaerinnen Trier, Germany, 54290 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medizinische Fakultät Carl Gustav Carus Dresden, Germany, 01307 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Universitätsklinikum Köln Köln, Germany, 50924 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Mannheim gGmbH Mannheim, Germany, 68167 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kliniken der Medizinischen Hochschule Hannover Hannover, Germany, 30625 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Vincentius-Kliniken gAG Karlsruhe, Germany, 76137 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinikum Leverkusen gGmbH Leverkusen, Germany, 51375 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Santee Hematology/Oncology Sumter, United States, 29150 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Facey Medical Foundation Mission Hills, United States, 91345 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beverly Hills Cancer Center Beverly Hills, United States, 90211 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UC Irvine Medical Center Orange, United States, 92868 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Scranton Hematology-Oncology Scranton, United States, 18510 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Capital Comprehensive Cancer Care Clinic Jefferson City, United States, 65109 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jersey Shore University Medical Center Neptune, United States, 07754 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Loma Linda Oncology Medical Group, Inc. Redlands, United States, 92374 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Innovative Medical Research of South Florida Aventura, United States, 33180 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Beth Israel Comprehensive Cancer Center New York, United States, 10011 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Southern California Los Angeles, United States, 90033 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Texas Southwestern Medical Center Dallas, United States, 75390-9110 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Illinois CancerCare, PC Peoria, United States, 61615-7828 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ochsner Foundation Hospital New Orleans, United States, 70121 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jersey Shore University Medical Center Neptune, United States, 07754 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Mayo Clinic - Jacksonville Jacksonville, United States, 32224 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Toledo Clinic, Inc. Toledo, United States, 43623 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saint Joseph Mercy Health System Ann Arbor, United States, 48106 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oncology Associates at Mercy Medical Center Cedar Rapids, United States, 52403 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CLINIQUE SAINTE CATHERINE Avignon, France, 84000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CAC Strasbourg Cedex, France, 67085 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations London Regional Cancer Program London, Canada, N6A 4L6 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sir Mortimer B. Davis Jewish General Hospital Montreal, Canada, H3T 1E2 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Credit Valley Hospital - Trillium Health Partners Mississauga, Canada, L5M 2N1 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lakeridge Health-Oshawa Oshawa, Canada, L1G 2B9 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CHUQ-Hopital Hotel-Dieu de Quebec Quebec, Canada, G1R 2J6 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations British Columbia Cancer Agency-Vancouver Centre Vancouver, Canada, V5Z 4E6 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Moncton Hospital Moncton, Canada, E1C 6Z8 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Boniface General Hospital Winnipeg, Canada, R2H 2A6 | Status Terminated | Contact Us: E-mail: clinical-trials[email protected] Phone: Not Available |
Locations Spaarne Ziekenhuis HOOFDDORP, Netherlands, 2134 TM | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Leids Universitair Medisch Centrum Leiden, Netherlands, 2333 ZA | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medisch Centrum Leeuwarden LEEUWARDEN, Netherlands, 8901 BR | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Vrije Universiteit Medisch Centrum AMSTERDAM, Netherlands, 1081 HV | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hosp. Mun. de Gastroenterología Dr. Carlos Bonorino Udaondo Buenos Aires, Argentina, C1264AAA | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Medico Especializado Alexander Fleming Capital Federal-Buenos Aires, Argentina, C1426ANZ | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Argentino de Diagnóstico y Tratamiento Buenos Aires, Argentina, C1122AAL | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro para la Atención Integral del Paciente Oncológico San Miguel de Tucumán, Argentina, T4000GTB | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto C.A.I.C.I. Rosario, Argentina, S2000PBJ | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Central Coast Medical Oncology Santa Maria, United States, 93454 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Charleston Hematology & Oncology Associates, PA Charleston, United States, 29414 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Utah Cancer Specialists Salt Lake City, United States, 84106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St. Cloud Hospital St. Cloud, United States, 56303 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Care Institute Los Angeles, United States, 90036 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sanford Roger Maris Cancer Center Fargo, United States, 58122 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Klinik für Tumorbiologie Freiburg Freiburg, Germany, 79106 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kumamoto University Hospital Kumamoto, Japan, 860-8556 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyushu University Hospital Fukuoka, Japan, 812-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Chiba Cancer Center Chiba, Japan, 260-8717 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jichi Medical University Hospital Shimotsuke, Japan, 329-0498 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyorin University Hospital Mitaka, Japan, 181-8611 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tochigi Cancer Center Utsunomiya, Japan, 320-0834 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hokkaido University Hospital Sapporo, Japan, 060-8648 | 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 National Hospital Organization Shikoku Cancer Center Matsuyama, Japan, 791-0280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Medical University International Medical Center Hidaka, Japan, 350-1298 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Osaka Medical College Hospital Takatsuki, Japan, 569-8686 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kochi Health Sciences Center Kochi, Japan, 781-8555 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Medical and Dental University Medical Hospital Bunkyo-ku, Japan, 113-8519 | 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 National Cancer Center Hospital Chuo-ku, Japan, 104-0045 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Saitama Cancer Center Kita-Adachigun, Japan, 362-0806 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shizuoka Cancer Center Sunto, Japan, 411-8777 | 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 National Hospital Organization Osaka Medical Hospital Osaka, Japan, 540-0006 | Status Completed | 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 Green Bay Oncology Green Bay, United States, 54303 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sunnybrook Health Sciences Centre Toronto, Canada, M4N 3M5 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Hospitalar e Universitário de Coimbra Coimbra, Portugal, 3030-075 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hei Long Jiang province tumor hospital ha'erbin, China, 150040 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Hospital, Chinese Academy of Medical Sciences Beijing, China, 100021 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fudan University Shanghai Cancer Center Shanghai, China, 200030 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations the Affiliated Hosp of med college Qingdao Uni Qingdao, China, 266100 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nanfang Hospital, Southern Medical University Guangzhou, China, 510515 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Shanghai Renji Hospital shanghai, China, 200001 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fuzhou General Hospital fuzhou, China, 350025 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Third Affiliated Hospital of Third Military Medical Univ chongqing, China, 400042 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peoples's Liberation Army 307th Hospital Beijing, China, 100071 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sun Yat-sen University Cancer Center Guangzhou, China, 510060 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fujian Provincial Tumor Hospital fuzhou, China, 350014 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 81 Hospital of Chinese PLA Nanjing, China, 210003 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tianjin Medical University Cancer Hospital Tianjin, China, 300060 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations 1st Affiliated Hospital of College Medicine, Zhejiang Univer Hanghzou, China, 310009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cancer Hospital of Jiangsu Province Nanjing, China, 210009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The First Affilicated Hospital of 3rd Military Med. Uni.PLA Chongqing, China, 400038 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Jilin provincial Tumor Hospital Changchun, China, 130021 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus BSC versus placebo plus BSC in patients with metastatic colorectal cancer (CRC) who have progressed after standard therapy
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 the database cut-off approximately 14 months later (19May2010 - 21Jul2011) used for 2nd planned formal interim analysis (IA).
Secondary Outcome
- Progression-free survival (based on investigator’s assessment)Timeframe: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
- Objective tumor responseTimeframe: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
- Disease controlTimeframe: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
- Tumor responseTimeframe: From randomization of the first subject until the database cut-off approximately 14 months later (19May2012 - 21Jul2011) used for 2nd planned formal interim analysis. Tumor assessed at 8 week intervals.
Additional Information
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