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:

NCT00863746

EudraCT Number:

2008-006914-62

Study Completed

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
703
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
Yes
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Krankenhaus Grosshansdorf

Großhansdorf, Germany, 22927

Status
Completed
 
Locations

Asklepios Fachkliniken München Gauting

Gauting, Germany, 82131

Status
Completed
 
Locations

Asklepios Klinik Harburg

Hamburg, Germany, 21075

Status
Terminated
 
Locations

St. Vincentius-Kliniken gAG

Karlsruhe, Germany, 76137

Status
Completed
 
Locations

Royal Marsden NHS Trust (Surrey)

Sutton, United Kingdom, SM2 5PT

Status
Completed
 
Locations

Royal Marsden Hospital (London)

London, United Kingdom, SW3 6JJ

Status
Completed
 
Locations

Aberdeen Royal Infirmary

Aberdeen, United Kingdom, AB25 2ZN

Status
Completed
 
Locations

Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Status
Completed
 
Locations

Southmead Hospital

Bristol, United Kingdom, BS10 5NB

Status
Completed
 
Locations

Highlands Oncology Group

Fayetteville, United States, 72703

Status
Completed
 
Locations

Centre Georges Francois Leclerc Dijon

DIJON, France, 21000

Status
Completed
 
Locations

Hôpital de la Croix Rousse

LYON CEDEX, France, 69317

Status
Completed
 
Locations

Hôpital Bretonneau - Tours

TOURS, France, 37044

Status
Completed
 
Locations

Kliniken der Stadt Köln - Städt. Krankenhaus Köln-Merheim

Köln, Germany, 51109

Status
Completed
 
Locations

Thoraxklinik-Heidelberg gGmbH

Heidelberg, Germany, 69126

Status
Completed
 
Locations

St James' University Hospital

Leeds, United Kingdom, LS9 7TF

Status
Completed
 
Locations

Royal Free Hospital

London, United Kingdom, NW3 2QG

Status
Completed
 
Locations

Christie Hospital

Greater Manchester, United Kingdom, M20 4BX

Status
Completed
 
Locations

Stanford Hospital & Clinics

Stanford, United States, 94305

Status
Completed
 
Locations

Centre René Gauducheau - Nantes

SAINT HERBLAIN, France, 44805

Status
Completed
 
Locations

Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego

Szczecin, Poland, 70-891

Status
Completed
 
Locations

Szpital Miejski sw. Aleksandra

Kielce, Poland, 25-316

Status
Terminated
 
Locations

Kinki University Hospital

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Kinki-Chuo Chest Medical Center

Sakai, Japan, 591-8555

Status
Completed
 
Locations

National Cancer Center Hospital East

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

A.O. San Camillo-Forlanini

Roma, Italy, 00151

Status
Completed
 
Locations

A.O.U. di Perugia

Perugia, Italy, 06156

Status
Completed
 
Locations

A.O. San Gerardo di Monza

Monza, Italy, 20052

Status
Completed
 
Locations

Centre Oscar Lambret

Lille, France, 59020

Status
Completed
 
Locations

Center Hospitalier Michallon - Grenoble

LA TRONCHE, France, 38700

Status
Completed
 
Locations

Centre François Baclesse - CLCC - Caen

CAEN, France, 14073

Status
Completed
 
Locations

Centrum Onkologii Instytut im. M. Sklodowskiej-Curie

Krakow, Poland, 31-115

Status
Completed
 
Locations

Instytut Gruzlicy i Chorob Pluc

Warszawa, Poland, 01-138

Status
Completed
 
Locations

NZOZ MRUKMED 2 Sp. p., Przychodnia Specjalistyczna

Rzeszow, Poland, 35-021

Status
Completed
 
Locations

Samodzielny Publiczny Zespól Gruzlicy i Chorób Pluc

Olsztyn, Poland, 10-357

Status
Completed
 
Locations

Teikyo University Hospital

Itabashi-ku, Japan, 173-8606

Status
Completed
 
Locations

The Cancer Institute Hospital of JFCR

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Hyogo Cancer Center

Akashi, Japan, 673-8558

Status
Completed
 
Locations

National Kyushu Cancer Center

Fukuoka, Japan, 811-1395

Status
Completed
 
Locations

Aichi Cancer Center Hospital

Nagoya, Japan, 464-8681

Status
Completed
 
Locations

IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

Status
Completed
 
Locations

A.O.U. di Parma

Parma, Italy, 43100

Status
Completed
 
Locations

AUSL 06 Livorno - Toscana

Livorno, Italy, 57124

Status
Completed
 
Locations

A.O.U. San Luigi Gonzaga

Orbassano, Italy, 10043

Status
Completed
 
Locations

A.O. San Giuseppe Moscati

Avellino, Italy, 83100

Status
Completed
 
Locations

Hospital Regional Carlos Haya

Málaga, Spain, 29010

Status
Completed
 
Locations

Complejo Hospitalario de Zamora

Zamora, Spain, 49021

Status
Completed
 
Locations

Hospital de Cruces

Cruces/Barakaldo, Spain, 48903

Status
Completed
 
Locations

Hospital de la Santa Creu i de Sant Pau

Barcelona, Spain, 08025

Status
Completed
 
Locations

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Spain, 25198

Status
Completed
 
Locations

Hopsital Lucus Agustí

Lugo, Spain, 27003

Status
Completed
 
Locations

Isala Klinieken, Locatie Sophia

ZWOLLE, Netherlands, 8025 AB

Status
Completed
 
Locations

Skånes Universitetssjukhus

Lund, Sweden, 221 85

Status
Completed
 
Locations

Karolinska Universitetssjukhuset i Solna

Stockholm, Sweden, 171 76

Status
Completed
 
Locations

Falu Lasarett

Falun, Sweden, 791 82

Status
Completed
 
Locations

Langehoven Drive Oncology Centre

Port Elizabeth, South Africa, 6045

Status
Completed
 
Locations

Dr Pirjol, Szpak 7 Moodley

Durban, South Africa, 4126

Status
Completed
 
Locations

Meir Medical Center

Kfar Saba, Israel, 4428164

Status
Completed
 
Locations

Assaf Harofeh Medical Center

Zrifin, Israel, 6093000

Status
Completed
 
Locations

Shaare Zedek Medical Center

Jerusalem, Israel, 9372212

Status
Completed
 
Locations

IRCCS Ist Nazionale Tumori GE

Genova, Italy, 16132

Status
Completed
 
Locations

Hospital Universitario Virgen del Rocío

Sevilla, Spain, 41013

Status
Completed
 
Locations

Hospital Clínic i Provincial de Barcelona

Barcelona, Spain, 08036

Status
Completed
 
Locations

Hospital Clínico Universitario San Carlos

Madrid, Spain, 28040

Status
Terminated
 
Locations

Complejo Hospitalario de Orense

Orense, Spain, 32005

Status
Completed
 
Locations

McGill University

Montreal, Canada, H2W 1S6

Status
Completed
 
Locations

CU Saint-Luc/UZ St-Luc

BRUXELLES - BRUSSEL, Belgium, 1200

Status
Completed
 
Locations

Ziekenhuis Oost-Limburg

GENK, Belgium, 3600

Status
Completed
 
Locations

ZNA Middelheim

ANTWERPEN, Belgium, 2020

Status
Terminated
 
Locations

Grand Hôpital de Charleroi

CHARLEROI, Belgium, 6000

Status
Completed
 
Locations

St. Antonius Ziekenhuis

NIEUWEGEIN, Netherlands, 3435 CM

Status
Completed
 
Locations

Vrije Universiteit Medisch Centrum

Amsterdam, Netherlands, 1081HV

Status
Completed
 
Locations

Atrium Medisch Centrum Parkstad

HEERLEN, Netherlands, 6419 PC

Status
Completed
 
Locations

Ziekenhuis St. Jansdal

HARDERWIJK, Netherlands, 3844 DG

Status
Completed
 
Locations

Elkerliek Ziekenhuis, Lokatie Helmond

HELMOND, Netherlands, 5707 HA

Status
Completed
 
Locations

Hadassah Hebrew University Hospital Ein Kerem

Jerusalem, Israel, 9112001

Status
Completed
 
Locations

District Dispensary for Oncology Diseases with Inpatient

Plovdiv, Bulgaria

Status
Completed
 
Locations

Interdistrict Dispensary for Oncological Diseases Dr.M.Marko

Varna, Bulgaria, 9002

Status
Completed
 
Locations

MHAT Sveta Marina EAD

Varna, Bulgaria, 9010

Status
Completed
 
Locations

Consultorios Médicos Privados

Ramos Mejía, Argentina, B1704ESN

Status
Terminated
 
Locations

Hospital Privado de Córdoba

Córdoba, Argentina, X5016KEH

Status
Terminated
 
Locations

Krankenhaus der Elisabethinen Linz

Linz, Austria, 4010

Status
Completed
 
Locations

Pest County Lung Institute

Torokbalint, Hungary, 2045

Status
Completed
 
Locations

Zala Megyei Korhaz

Zalaegerszeg, Hungary, 8900

Status
Completed
 
Locations

Orszagos Koranyi TBC es Pulmonologiai Intezet

Budapest, Hungary, 1529

Status
Completed
 
Locations

Hospital e Maternidade Brasil

Santo André, Brazil, 09020 110

Status
Completed
 
Locations

Hospital Israelita Albert Einstein

São Paulo, Brazil, 05651-900

Status
Completed
 
Locations

Irmandade Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Brazil, 90050 170

Status
Completed
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Completed
 
Locations

Universitetssjukhuset i Linköping

Linköping, Sweden, 581 85

Status
Completed
 
Locations

University of Pretoria, Prinshof Campus

Prietoria, South Africa, 0084

Status
Completed
 
Locations

Medcial Oncology Centre Rosebank

Johannesburg, South Africa, 2196

Status
Terminated
 
Locations

Panorama GVI Oncology

Cape Town, South Africa, 7500

Status
Terminated
 
Locations

Edith Wolfson Medical Center

Holon, Israel

Status
Completed
 
Locations

Rabin Medical Center - Beilinson Campus

Petach Tikva, Israel, 4941492

Status
Completed
 
Locations

District Dispensary for Oncology Diseases with Inpatient

Sofia, Bulgaria, 1784

Status
Completed
 
Locations

Specialized Hospital for Active Treatment of Oncology

Sofia, Bulgaria

Status
Completed
 
Locations

Centro Especializado ISIS

Santa Fé, Argentina, S3000FFV

Status
Terminated
 
Locations

Centro Oncológico de Rosario

Rosario, Argentina, S2000DSK

Status
Terminated
 
Locations

Instituto Oncológico Dr. J. M. Urrutia

Córdoba, Argentina, 5000

Status
Terminated
 
Locations

Instituto C.A.I.C.I.

Rosario, Argentina, 2000

Status
Terminated
 
Locations

PALIAR

Buenos Aires, Argentina, C1430ERF

Status
Terminated
 
Locations

Medizinische Universität Graz

Graz, Austria, 8036

Status
Completed
 
Locations

Instituto de Oncologia do Vale

São José dos Campos, Brazil, 12245750

Status
Completed
 
Locations

Clinical Oncology Dispensary

Kazan, Russia, 420029

Status
Completed
 
Locations

Clinical Oncology Hospital

Yaroslavl, Russia, 150054

Status
Terminated
 
Locations

Shanghai Pulmonary Hospital, Tongji University

Shanghai, China, 200433

Status
Completed
 
Locations

Chinese PLA General Hosp.

Beijing, China, 100853

Status
Completed
 
Locations

Sir Run Run Shaw Hospital

Hangzhou, China, 310016

Status
Completed
 
Locations

National Cancer Center DHARMAIS

Jakarta, Indonesia, 11420

Status
Completed
 
Locations

Asan Medical Center

Seoul, South Korea, 138-736

Status
Completed
 
Locations

Seoul St. Mary's Hospital

Seoul, South Korea, 137-701

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 10016

Status
Completed
 
Locations

Taichung Veterans General Hospital

Taichung, Taiwan, China, 40705

Status
Completed
 
Locations

Kaohsiung Medical University Hospital

Kaohsiung , Taiwan, China, 80756

Status
Completed
 
Locations

Hospital Edgardo Rebagliati Martins

Lima, Peru, LIMA 11

Status
Completed
 
Locations

Hospital Nacional Guillermo Almenara Irigoyen

Lima, Peru, LIMA 1

Status
Completed
 
Locations

Princess Margaret Hospital

Kowloon, Hong Kong, China

Status
Terminated
 
Locations

Allgemeines Krankenhaus der Stadt Wien Universitätskliniken

Wien, Austria, 1090

Status
Terminated
 
Locations

Instituto Nacional del Cancer

Santiago, Chile, 838-0455

Status
Completed
 
Locations

Hospital Clínico Universidad de Chile

Santiago, Chile, 838-0456

Status
Completed
 
Locations

Veszprem County Pulmonology Institute

Farkasgyepu, Hungary, 8582

Status
Completed
 
Locations

Ege Universitesi Tip Fakultesi

Izmir, Turkey

Status
Completed
 
Locations

Marmara University Medical Faculty

INSTANBUL, Turkey, 34662

Status
Completed
 
Locations

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey

Status
Completed
 
Locations

Anadolu Saglik Merkezi

Kocaeli, Turkey, 41400

Status
Completed
 
Locations

Ankara Universitesi Tip Fakultesi

Ankara, Turkey

Status
Completed
 
Locations

University General Hospital of Heraklion

Heraklion, Greece, 711 10

Status
Completed
 
Locations

Sotiria General State Hospital of Chest Diseases

Athens, Greece, 11527

Status
Completed
 
Locations

G. Papanikolaou General Hospital of Thessaloniki

Thessaloniki, Greece, 570 10

Status
Completed
 
Locations

Grupo de Assistencia Medica e Prestacao de Servicos Ltda

Sao Paulo, Brazil, 01224-010

Status
Completed
 
Locations

Veterans Memorial Medical Center

Quezon City, Philippines, 1104

Status
Completed
 
Locations

Perpetual Succour Hospital

Cebu City, Philippines, 6000

Status
Completed
 
Locations

Manila Doctors Hospital

Metro Manila, Philippines, 1000

Status
Completed
 
Locations

National University Cancer Institute, Singapore

Singapore, Singapore, 119228

Status
Completed
 
Locations

Johns Hopkins Singapore IMC

Singapore , Singapore, 308433

Status
Completed
 
Locations

Maharaj Nakorn Chiang Mai Hospital

Chiang Mai , Thailand, 50200

Status
Completed
 
Locations

Mayo Hospital

Lahore, Pakistan, 54000

Status
Completed
 
Locations

BioCancer

Belo Horizonte, Brazil, 30150-281

Status
Completed
 
Locations

Hospital Sao Lucas da Pontificia Universidade Catolica do RS

Porto Alegre, Brazil, 90610-000

Status
Completed
 
Locations

Centro Especializado en Oncología y Hematología Brasilia

Brasilia, Brazil, 70680-650

Status
Terminated
 
Locations

Railways Hospital named after Semashko

Moscow, Russia, 129128

Status
Completed
 
Locations

Russian Oncological Scientific Center n.a. N.N. Blokhin RAMS

Moscow, Russia, 115478

Status
Completed
 
Locations

City Clinical Oncology Center

St. Petersburg, Russia, 198255

Status
Completed
 
Locations

Moscow Clinical Oncology Dispensary n. 1

Moscow, Russia, 105 005

Status
Terminated
 
Locations

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, China, 100021

Status
Completed
 
Locations

Guangdong General Hospital

Guangzhou, China, 510080

Status
Completed
 
Locations

Sun Yat-sen University Cancer Center

Guangzhou, China, 510060

Status
Completed
 
Locations

Shanghai Chest Hospital, Shanghai Jiaotong University

Shanghai, China, 200030

Status
Completed
 
Locations

PLA 81 Hospital

Nanjing, China, 210002

Status
Completed
 
Locations

Peking University Cancer Hospital

Beijing, China, 100142

Status
Completed
 
Locations

307 Hospital of PLA

Beijing, China, 100071

Status
Completed
 
Locations

Zhejiang Cancer Hospital

Hangzhou, China, 310022

Status
Completed
 
Locations

West China Hospital, Sichuan University

Chengdu, China, 610041

Status
Completed
 
Locations

Hasan Sadikin Hospital

Bandung , Indonesia, 40161

Status
Terminated
 
Locations

Korea University Anam Hospital

Seoul, South Korea, 136-705

Status
Completed
 
Locations

Seoul National University Hospital

Seoul, South Korea, 110-744

Status
Completed
 
Locations

Samsung Medical Center

Seoul, South Korea, 135-710

Status
Completed
 
Locations

Curie Manavata Cancer Centre

Mumbai, India, 422004

Status
Completed
 
Locations

Lakeshore Hospital and Research Center Ltd

Kerala, India, 682304

Status
Completed
 
Locations

Ruby Hall Clinic

Pune, India, 411001

Status
Completed
 
Locations

Chang Gung Memorial Hospital at Linkou

Taoyuan, Taiwan, China, 333

Status
Completed
 
Locations

China Medical University Hospital

Taichung, Taiwan, China, 404

Status
Completed
 
Locations

Clínica El Golf

Lima, Peru, LIMA 27

Status
Terminated
 
Locations

Hospital Alberto Sabogal Sologuren

Callao, Peru, CALLAO 2

Status
Completed
 
Locations

Oncosalud

San Borja, Peru

Status
Terminated
 
Locations

Prince of Wales Hospital

Shatin, Hong Kong, China

Status
Completed
 
Locations

Queen Mary Hospital

Hongkong, Hong Kong, China

Status
Completed
 
Locations

Santo Tomás University Hospital

Manila, Philippines, 1000

Status
Completed
 
Locations

Siriraj Hospital, Mahidol

Bangkok, Thailand, 10700

Status
Completed
 
Locations

Prince of Songkla University

Songkhla, Thailand, 90110

Status
Completed
 
Locations

Dr Ziauddin Hospital

Karachi, Pakistan, 74700

Status
Completed
 
Locations

Centre Hospitalier Départemental-La Roche sur Yon

LA ROCHE SUR YON CEDEX, France, 85025

Status
Completed
 
Locations

Koch Robert Hospital

Edeleny, Hungary, 3780

Status
Completed
 
Locations

University of Semmelweis

Budapest, Hungary, 1125

Status
Completed
 
Locations

Rittenhouse Hematology/Oncology

Philadelphia , United States, 19107

Status
Terminated
 
Locations

Zentralklinik Bad Berka GmbH

Bad Berka, Germany, 99437

Status
Completed
 
Locations

Klinikum Innenstadt der Ludwigs-Maximilians-Universität

München, Germany, 80336

Status
Terminated
 
Locations

Klinikum Mannheim gGmbH

Mannheim, Germany, 68167

Status
Terminated
 
Locations

Klinikum Kassel GmbH

Kassel, Germany, 34125

Status
Terminated
 
Locations

Universitätsklinikum Ulm

Ulm, Germany, 89091

Status
Completed
 
Locations

Instituto Nacional de Enfermedades Neoplásicas

Lima, Peru, LIMA 34

Status
Terminated
 

Trial Design