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:

NCT01103323

EudraCT Number:

2009-012787-14

Study Completed

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
760
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Stivarga (Regorafenib, BAY73-4506)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Med. Fakultät der Martin-Luther-Universität Halle-Wittenberg

Halle, Germany, 06120

Status
Completed
 
Locations

Klinikum Oldenburg GmbH

Oldenburg, Germany, 26133

Status
Completed
 
Locations

Mayo Clinic - Rochester

Rochester, United States, 55905

Status
Completed
 
Locations

CHRU Lille - Cedex

LILLE CEDEX, France, 59037

Status
Completed
 
Locations

Clinique Victor Hugo - Le Mans

LE MANS CEDEX 2, France, 72015

Status
Completed
 
Locations

Centre Eugène Marquis - Rennes Cedex

RENNES, France, 35042

Status
Terminated
 
Locations

A.O. Osp Niguarda Ca' Granda

Milano, Italy, 20162

Status
Completed
 
Locations

Fondazione Poliambulanza - Istituto Ospedaliero

Brescia, Italy, 25124

Status
Completed
 
Locations

A.O.U. Seconda Università

Napoli, Italy, 80131

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Hospital Universitario 12 de Octubre

Madrid, Spain, 28041

Status
Completed
 
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
 
Locations

Hospital Universitario "La Paz"

Madrid, Spain, 28046

Status
Completed
 
Locations

UZ Leuven Gasthuisberg

LEUVEN, Belgium, 3000

Status
Completed
 
Locations

Onkologische Schwerpunktpraxis

Porta Westfalica, Germany, 32457

Status
Completed
 
Locations

Marienhospital

Stuttgart, Germany, 70199

Status
Completed
 
Locations

LMU Klinikum der Universität München - Großhadern

München, Germany, 81377

Status
Completed
 
Locations

Städt. Klinikum München

München, Germany, 81737

Status
Completed
 
Locations

HELIOS Klinikum Berlin - Buch

Berlin, Germany, 13125

Status
Completed
 
Locations

Schwerpunktpraxis für Hämatologie und Onkologie

Magdeburg, Germany, 39104

Status
Completed
 
Locations

Städtische Kliniken München GmbH

München, Germany, 81925

Status
Completed
 
Locations

Universitätsklinikum Essen

Essen, Germany, 45122

Status
Completed
 
Locations

Institut du Cancer de Montpellier

MONTPELLIER, France, 34298

Status
Completed
 
Locations

Hôpital Robert Debré - Reims Cedex

REIMS , France, 51092

Status
Completed
 
Locations

Hôpital de la Pitié-Salpétrière - Paris

PARIS, France, 75651

Status
Completed
 
Locations

Centre Oscar Lambret - Lille

LILLE CEDEX, France, 59020

Status
Active, not recruiting
 
Locations

Hôpital de la Timone - Marseille

MARSEILLE, France, 13005

Status
Completed
 
Locations

IRCCS A.O.U. San Martino – IST Ist. Nazionale Ricerca Cancro

Genova, Italy, 16132

Status
Completed
 
Locations

H.-Hartziekenhuis Roeselare

ROESELARE, Belgium, 8800

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

UZ Antwerpen

EDEGEM, Belgium, 2650

Status
Completed
 
Locations

Hôpital Erasme/Erasmus Ziekenhuis

BRUXELLES - BRUSSEL, Belgium, 1070

Status
Completed
 
Locations

Fakultni nemocnice Na Bulovce

Praha, Czech Republic, 18081

Status
Completed
 
Locations

Masarykuv onkologicky ustav

Brno, Czech Republic, 65 653

Status
Completed
 
Locations

Faculty Hospital Hradec Kralove

Hradec Kralove, Czech Republic, 500 05

Status
Completed
 
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 5262000

Status
Completed
 
Locations

Tel-Aviv Sourasky Medical Center

Tel Aviv, Israel, 6423906

Status
Completed
 
Locations

Kaplan Medical Center

Rehovot, Israel, 7610001

Status
Terminated
 
Locations

Edith Wolfson Medical Center

Holon, Israel

Status
Terminated
 
Locations

Assaf Harofeh Medical Center

Zrifin, Israel, 6093000

Status
Terminated
 
Locations

Concord Repatriation General Hospital

Concord, Australia, 2139

Status
Completed
 
Locations

Princess Alexandra Hospital

Woolloogabba, Australia, 4102

Status
Terminated
 
Locations

Queen Elizabeth Hospital

Woodville South, Australia, 5011

Status
Completed
 
Locations

A.O.R.N. Antonio Cardarelli

Napoli, Italy, 80131

Status
Completed
 
Locations

A.O.U. di Modena Policlinico

Modena, Italy, 41124

Status
Completed
 
Locations

A.O.U. Pisana

Pisa, Italy, 56126

Status
Completed
 
Locations

Università Cattolica del Sacro Cuore

Roma, Italy, 00168

Status
Completed
 
Locations

A.O. di Reggio Emilia

Reggio Emilia, Italy, 42100

Status
Completed
 
Locations

IRCCS Istituto Nazionale Tumori

Milano, Italy, 20133

Status
Terminated
 
Locations

Ciutat Sanitària i Universitaria de la Vall d'Hebron

Barcelona, Spain, 08035

Status
Completed
 
Locations

Corporació Sanitària Parc Taulí

Sabadell, Spain, 08208

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Completed
 
Locations

Institut Català d'Oncologia

Hospitalet de Llobregat, Spain, 08907

Status
Completed
 
Locations

Institut Jules Bordet/Jules Bordet Instituut

BRUXELLES - BRUSSEL, Belgium, 1000

Status
Completed
 
Locations

Fakultni Nemocnice Olomouc

Olomouc, Czech Republic, 775 20

Status
Completed
 
Locations

Rambam Health Corporation

Haifa, Israel, 3109601

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

Hospital Santo António Oporto

Porto, Portugal, 4099-001

Status
Terminated
 
Locations

Instituto Portugues de Oncologia de Francisco Gentil

Porto, Portugal, 4200-072

Status
Terminated
 
Locations

Gazi Univ. Medical Faculty

Ankara, Turkey, 06500

Status
Completed
 
Locations

Hospital Lifecenter

Belo Horizonte, Brazil, 30110-090

Status
Terminated
 
Locations

Barzilai Medical Center

Ashkelon, Israel, 7830604

Status
Terminated
 
Locations

Soroka University Medical Center

Beer Sheva, Israel, 8410101

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 4941492

Status
Completed
 
Locations

Royal Melbourne Hospital

Parkville, Australia, 3050

Status
Completed
 
Locations

Western Hospital

Footscray, Australia, 3011

Status
Completed
 
Locations

Royal North Shore Hospital

St Leonards, Australia, 2065

Status
Completed
 
Locations

Centro Hospitalar de Lisboa Norte - Hospital Santa Maria

Lisboa, Portugal, 1649-035

Status
Terminated
 
Locations

Hospital Infante Dom Pedro

Aveiro , Portugal, 3810-096

Status
Terminated
 
Locations

Jósa András Oktató Kórház

Nyiregyhaza, Hungary, 4400

Status
Terminated
 
Locations

University of Debrecen

Debrecen, Hungary, 4032

Status
Completed
 
Locations

Semmelweis Egyetem AOK

Budapest, Hungary, 1082

Status
Terminated
 
Locations

Altalanos Orvostudomanyi Kar

Szeged, Hungary, 6725

Status
Completed
 
Locations

Ege Universitesi Tip Fakultesi

Izmir, Turkey, 35100

Status
Terminated
 
Locations

Istanbul Univ. Medical Faculty, DETAM

Istanbul, Turkey, 34390

Status
Completed
 
Locations

Marmara University Medical Faculty

INSTANBUL, Turkey, 34662

Status
Terminated
 
Locations

Oncoclinic

Fortaleza, Brazil, 60160-230

Status
Terminated
 
Locations

Associação Hospital de Caridade de Ijuí

Ijuí, Brazil, 98700-000

Status
Terminated
 
Locations

Clinica AMO

Salvador, Brazil, 41830-492

Status
Terminated
 
Locations

Hôpital Cantonal Universitaire de Genève

Genève, Switzerland, 1211

Status
Completed
 
Locations

Kantonsspital Graubünden

Chur, Switzerland, 7000

Status
Terminated
 
Locations

Krankenanstalt Mutterhaus der Borromaerinnen

Trier, Germany, 54290

Status
Completed
 
Locations

Medizinische Fakultät Carl Gustav Carus

Dresden, Germany, 01307

Status
Completed
 
Locations

Universitätsklinikum Köln

Köln, Germany, 50924

Status
Completed
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Completed
 
Locations

Kliniken der Medizinischen Hochschule Hannover

Hannover, Germany, 30625

Status
Completed
 
Locations

St. Vincentius-Kliniken gAG

Karlsruhe, Germany, 76137

Status
Terminated
 
Locations

Klinikum Leverkusen gGmbH

Leverkusen, Germany, 51375

Status
Terminated
 
Locations

Santee Hematology/Oncology

Sumter, United States, 29150

Status
Completed
 
Locations

Facey Medical Foundation

Mission Hills, United States, 91345

Status
Terminated
 
Locations

Beverly Hills Cancer Center

Beverly Hills, United States, 90211

Status
Terminated
 
Locations

UC Irvine Medical Center

Orange, United States, 92868

Status
Terminated
 
Locations

Scranton Hematology-Oncology

Scranton, United States, 18510

Status
Completed
 
Locations

Capital Comprehensive Cancer Care Clinic

Jefferson City, United States, 65109

Status
Completed
 
Locations

Jersey Shore University Medical Center

Neptune, United States, 07754

Status
Terminated
 
Locations

Loma Linda Oncology Medical Group, Inc.

Redlands, United States, 92374

Status
Terminated
 
Locations

Innovative Medical Research of South Florida

Aventura, United States, 33180

Status
Completed
 
Locations

Beth Israel Comprehensive Cancer Center

New York, United States, 10011

Status
Terminated
 
Locations

University of Southern California

Los Angeles, United States, 90033

Status
Completed
 
Locations

University of Texas Southwestern Medical Center

Dallas, United States, 75390-9110

Status
Completed
 
Locations

Illinois CancerCare, PC

Peoria, United States, 61615-7828

Status
Completed
 
Locations

Ochsner Foundation Hospital

New Orleans, United States, 70121

Status
Completed
 
Locations

Jersey Shore University Medical Center

Neptune, United States, 07754

Status
Completed
 
Locations

Mayo Clinic - Jacksonville

Jacksonville, United States, 32224

Status
Completed
 
Locations

The Toledo Clinic, Inc.

Toledo, United States, 43623

Status
Completed
 
Locations

Saint Joseph Mercy Health System

Ann Arbor, United States, 48106

Status
Completed
 
Locations

Oncology Associates at Mercy Medical Center

Cedar Rapids, United States, 52403

Status
Completed
 
Locations

CLINIQUE SAINTE CATHERINE

Avignon, France, 84000

Status
Completed
 
Locations

CAC

Strasbourg Cedex, France, 67085

Status
Completed
 
Locations

London Regional Cancer Program

London, Canada, N6A 4L6

Status
Completed
 
Locations

Sir Mortimer B. Davis Jewish General Hospital

Montreal, Canada, H3T 1E2

Status
Completed
 
Locations

Credit Valley Hospital - Trillium Health Partners

Mississauga, Canada, L5M 2N1

Status
Completed
 
Locations

Lakeridge Health-Oshawa

Oshawa, Canada, L1G 2B9

Status
Completed
 
Locations

CHUQ-Hopital Hotel-Dieu de Quebec

Quebec, Canada, G1R 2J6

Status
Terminated
 
Locations

British Columbia Cancer Agency-Vancouver Centre

Vancouver, Canada, V5Z 4E6

Status
Terminated
 
Locations

Moncton Hospital

Moncton, Canada, E1C 6Z8

Status
Completed
 
Locations

St. Boniface General Hospital

Winnipeg, Canada, R2H 2A6

Status
Terminated
 
Locations

Spaarne Ziekenhuis

HOOFDDORP, Netherlands, 2134 TM

Status
Terminated
 
Locations

Leids Universitair Medisch Centrum

Leiden, Netherlands, 2333 ZA

Status
Completed
 
Locations

Medisch Centrum Leeuwarden

LEEUWARDEN, Netherlands, 8901 BR

Status
Terminated
 
Locations

Vrije Universiteit Medisch Centrum

AMSTERDAM, Netherlands, 1081 HV

Status
Completed
 
Locations

Hosp. Mun. de Gastroenterología Dr. Carlos Bonorino Udaondo

Buenos Aires, Argentina, C1264AAA

Status
Terminated
 
Locations

Instituto Medico Especializado Alexander Fleming

Capital Federal-Buenos Aires, Argentina, C1426ANZ

Status
Terminated
 
Locations

Instituto Argentino de Diagnóstico y Tratamiento

Buenos Aires, Argentina, C1122AAL

Status
Terminated
 
Locations

Centro para la Atención Integral del Paciente Oncológico

San Miguel de Tucumán, Argentina, T4000GTB

Status
Terminated
 
Locations

Instituto C.A.I.C.I.

Rosario, Argentina, S2000PBJ

Status
Terminated
 
Locations

Central Coast Medical Oncology

Santa Maria, United States, 93454

Status
Completed
 
Locations

Charleston Hematology & Oncology Associates, PA

Charleston, United States, 29414

Status
Completed
 
Locations

Utah Cancer Specialists

Salt Lake City, United States, 84106

Status
Terminated
 
Locations

St. Cloud Hospital

St. Cloud, United States, 56303

Status
Terminated
 
Locations

Cancer Care Institute

Los Angeles, United States, 90036

Status
Completed
 
Locations

Sanford Roger Maris Cancer Center

Fargo, United States, 58122

Status
Terminated
 
Locations

Klinik für Tumorbiologie Freiburg

Freiburg, Germany, 79106

Status
Terminated
 
Locations

Kumamoto University Hospital

Kumamoto, Japan, 860-8556

Status
Completed
 
Locations

Kyushu University Hospital

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Chiba Cancer Center

Chiba, Japan, 260-8717

Status
Completed
 
Locations

Jichi Medical University Hospital

Shimotsuke, Japan, 329-0498

Status
Completed
 
Locations

Kyorin University Hospital

Mitaka, Japan, 181-8611

Status
Completed
 
Locations

Tochigi Cancer Center

Utsunomiya, Japan, 320-0834

Status
Completed
 
Locations

Hokkaido University Hospital

Sapporo, Japan, 060-8648

Status
Completed
 
Locations

The Cancer Institute Hospital of JFCR

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

National Hospital Organization Shikoku Cancer Center

Matsuyama, Japan, 791-0280

Status
Completed
 
Locations

Saitama Medical University International Medical Center

Hidaka, Japan, 350-1298

Status
Completed
 
Locations

Osaka Medical College Hospital

Takatsuki, Japan, 569-8686

Status
Completed
 
Locations

Kochi Health Sciences Center

Kochi, Japan, 781-8555

Status
Completed
 
Locations

Tokyo Medical and Dental University Medical Hospital

Bunkyo-ku, Japan, 113-8519

Status
Completed
 
Locations

Aichi Cancer Center Hospital

Nagoya, Japan, 464-8681

Status
Completed
 
Locations

National Cancer Center Hospital

Chuo-ku, Japan, 104-0045

Status
Completed
 
Locations

Saitama Cancer Center

Kita-Adachigun, Japan, 362-0806

Status
Completed
 
Locations

Shizuoka Cancer Center

Sunto, Japan, 411-8777

Status
Completed
 
Locations

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

National Hospital Organization Osaka Medical Hospital

Osaka, Japan, 540-0006

Status
Completed
 
Locations

Kinki University Hospital

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Green Bay Oncology

Green Bay, United States, 54303

Status
Terminated
 
Locations

Sunnybrook Health Sciences Centre

Toronto, Canada, M4N 3M5

Status
Completed
 
Locations

Centro Hospitalar e Universitário de Coimbra

Coimbra, Portugal, 3030-075

Status
Terminated
 
Locations

Hei Long Jiang province tumor hospital

ha'erbin, China, 150040

Status
Terminated
 
Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Status
Terminated
 
Locations

Fudan University Shanghai Cancer Center

Shanghai, China, 200030

Status
Terminated
 
Locations

the Affiliated Hosp of med college Qingdao Uni

Qingdao, China, 266100

Status
Terminated
 
Locations

Nanfang Hospital, Southern Medical University

Guangzhou, China, 510515

Status
Terminated
 
Locations

Shanghai Renji Hospital

shanghai, China, 200001

Status
Terminated
 
Locations

Fuzhou General Hospital

fuzhou, China, 350025

Status
Terminated
 
Locations

The Third Affiliated Hospital of Third Military Medical Univ

chongqing, China, 400042

Status
Terminated
 
Locations

Peoples's Liberation Army 307th Hospital

Beijing, China, 100071

Status
Completed
 
Locations

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

Status
Terminated
 
Locations

Fujian Provincial Tumor Hospital

fuzhou, China, 350014

Status
Terminated
 
Locations

81 Hospital of Chinese PLA

Nanjing, China, 210003

Status
Terminated
 
Locations

Tianjin Medical University Cancer Hospital

Tianjin, China, 300060

Status
Terminated
 
Locations

1st Affiliated Hospital of College Medicine, Zhejiang Univer

Hanghzou, China, 310009

Status
Terminated
 
Locations

Cancer Hospital of Jiangsu Province

Nanjing, China, 210009

Status
Terminated
 
Locations

The First Affilicated Hospital of 3rd Military Med. Uni.PLA

Chongqing, China, 400038

Status
Terminated
 
Locations

Jilin provincial Tumor Hospital

Changchun, China, 130021

Status
Terminated
 

Trial Design