Nintedanib (BIBF 1120) in Mesothelioma
- Conditions
- Mesothelioma
- Interventions
- Registration Number
- NCT01907100
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This is a phase II/III confirmatory study designed to evaluate the safety and efficacy of nintedanib (BIBF 1120) in combination + (pemetrexed / cisplatin) followed by nintedanib (BIBF 1120) versus placebo + pemetrexed / cisplatin followed by placebo for the treatment of patients with unresectable malignant pleural mesothelioma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 545
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo + pemetrexed/cisplatin Placebo Placebo controlled arm Placebo + pemetrexed/cisplatin Pemetrexed Placebo controlled arm Placebo + pemetrexed/cisplatin Cisplatin Placebo controlled arm Nintedanib 200mg + pemetrexed/cisplatin Nintedanib Experimental arm Nintedanib 200mg + pemetrexed/cisplatin Cisplatin Experimental arm Nintedanib 200mg + pemetrexed/cisplatin Pemetrexed Experimental arm
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months) This outcome measure presents progression-free survival. Disease progression was defined according to the modified Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Progression-free survival time was calculated as the duration from the date of randomization to the date of disease progression or death, whichever occurred first. For patients with known date of progression (or death): PFS (days) = min (date of progression, date of death) - date of randomization + 1 day. For patients without progression or death, PFS was censored at the last imaging date that showed no disease progression: PFS (days, censored) = date of last imaging showing no progression - date randomization + 1 day.
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) From randomization until the earliest of disease progression, death or (Phase II: cut-off date of 4-March-2016; up to 889 days) (Phase III: cut-off date of 16-March-2018; up to 31 months) Overall survival was defined as the duration of time from randomization to time of death.
This is the key secondary endpoint of the trial.Objective Response According to Modified RECIST- Investigator Assessment Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months Objective response (best overall tumour response of confirmed complete response \[CR\] or confirmed partial response \[PR\]).
Complete Response: disappearance of all target lesions Partial Response: at least a 30 % decrease in the total tumour measurement of target lesions, taking as reference the baseline total tumour measurement.
Percentage of Patients with confirmed objective response is presented. This endpoint was only evaluated for Phase III part.Disease Control According to Modified RECIST- Investigator Assessment Tumour imaging was to be performed every 6 weeks until disease progression, death or start of subsequent anti-cancer therapy, whichever occurred earlier; up to 54 months Disease control (best overall response of confirmed CR or PR, or Stable Disease (SD) that lasted ≥36 days) according to modified RECIST.
Percentage of Patients with Disease control is presented. This endpoint was only evaluated for Phase III part.
Trial Locations
- Locations (122)
Northern Cancer Institute
🇦🇺St Leonards, New South Wales, Australia
Texas Oncology - McAllen
🇺🇸McAllen, Texas, United States
Cancer Care Northwest Centers, PS
🇺🇸Spokane Valley, Washington, United States
Mater Cancer Care Centre
🇦🇺South Brisbane, Queensland, Australia
Clínica Universitaria Reina Fabiola
🇦🇷Ciudad de Cordoba, Argentina
Instituto Medico Especializado Alexander Fleming
🇦🇷Ciudad Autónoma de Bs As, Argentina
Texas Oncology-San Antonio Northeast
🇺🇸San Antonio, Texas, United States
Calvary Mater Newcastle Hospital
🇦🇺Waratah, New South Wales, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Perth Oncology
🇦🇺Perth, Western Australia, Australia
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi
🇹🇷Istanbul, Turkey
Onco.Cent. - Instit. of Maria Sklodowskiej-Curie
🇵🇱Warsaw, Poland
Nasser Institute
🇪🇬Cairo, Egypt
AKH - Medical University of Vienna
🇦🇹Vienna, Austria
Centro Oncologico Estatal ISSEMYM
🇲🇽Toluca, Mexico
IUCPQ (Laval University)
🇨🇦Quebec, Canada
Japan Labour Health and Safety Organization Okayama Rosai Hospital
🇯🇵Okayama, Okayama, Japan
SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan
🇷🇺Ufa, Russian Federation
University of California San Francisco
🇺🇸San Francisco, California, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Greenville Health System
🇺🇸Greenville, South Carolina, United States
The University of Texas MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
Sanatorio Güemes
🇦🇷Ciudad Autónoma de Bs As, Argentina
Peninsula Haematology & Oncology
🇦🇺Frankston, Victoria, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Austin Health
🇦🇺Heidelberg, Victoria, Australia
Border Onclogy Research
🇦🇺Wodonga, Victoria, Australia
LKH Leoben
🇦🇹Leoben, Austria
Klinikum Wels - Grieskirchen GmbH
🇦🇹Wels, Austria
Edegem - UNIV UZ Antwerpen
🇧🇪Edegem, Belgium
Brussels - UNIV Saint-Luc
🇧🇪Bruxelles, Belgium
UNIV UZ Gent
🇧🇪Gent, Belgium
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
QEII Health Sciences Centre (Dalhousie University)
🇨🇦Halifax, Nova Scotia, Canada
Health Sciences North
🇨🇦Sudbury, Ontario, Canada
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
Centro Internacional de Estudios Clínicos - CIEC
🇨🇱Recoleta, Chile
University Clinic for Pulmonary Diseases
🇭🇷Zagreb, Croatia
Orlandi Oncologia
🇨🇱Vitacura, Chile
University Hospital Brno
🇨🇿Brno, Czechia
Rigshospitalet, København, Onkologisk afdeling
🇩🇰Købenahvn Ø, Denmark
University Hospital Olomouc
🇨🇿Olomouc, Czechia
Medical Research Institute
🇪🇬Alexandria, Egypt
Clinical Research Center Alexandria
🇪🇬Alexandria, Egypt
CLI Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
HOP Côte de Nacre
🇫🇷Caen, France
National Cancer Institute, Cairo University
🇪🇬Cairo, Egypt
HOP Morvan
🇫🇷Brest, France
HOP Lyon Sud
🇫🇷Pierre-Bénite, France
HOP Calmette
🇫🇷Lille, France
INS Gustave Roussy
🇫🇷Villejuif, France
HOP Larrey
🇫🇷Toulouse, France
HOP Nord
🇫🇷Marseille, France
Helios Klinikum Emil von Behring
🇩🇪Berlin, Germany
Klinik Schillerhöhe GmbH
🇩🇪Gerlingen, Germany
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH
🇩🇪Großhansdorf, Germany
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Germany
Sourasky Medical Center
🇮🇱Tel-Aviv, Israel
Rabin Medical Center Beilinson
🇮🇱Petach Tikva, Israel
Universitätsklinikum des Saarlandes
🇩🇪Homburg/Saar, Germany
Klinik, Löwenstein
🇩🇪Löwenstein, Germany
Istituto Nazionale per la Ricerca sul Cancro
🇮🇹Genova, Italy
Humanitas Gavazzeni
🇮🇹Bergamo, Italy
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo
🇮🇹Alessandria, Italy
Centro di riferimento Oncologico
🇮🇹Aviano (PN), Italy
Azienda Sanitaria Ospedale S. Luigi Gonzaga
🇮🇹Orbassano (TO), Italy
A.O.U. Senese Policlinico Santa Maria alle Scotte
🇮🇹Siena, Italy
University Hospital of Occupational and Environmental Health
🇯🇵Fukuoka, Kitakyushu, Japan
Hyogo Prefectural Amagasaki General Medical Center
🇯🇵Hyogo, Amagasaki, Japan
Hyogo College of Medicine Hospital
🇯🇵Hyogo, Nishinomiya, Japan
Yokosuka Kyosai Hospital
🇯🇵Kanagawa , Yokosuka, Japan
Kindai University Hospital
🇯🇵Osaka, OsakaSayama, Japan
Otemae Hospital
🇯🇵Osaka, Osaka, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Centro Oncologico de Chihuahua
🇲🇽Chihuahua, Mexico
Instituto Nacional de Cancerologia
🇲🇽Mexico, Mexico
Medisch Spectrum Twente
🇳🇱Enschede, Netherlands
Oslo Universitetssykehus HF, Radiumhospitalet
🇳🇴Oslo, Norway
St. Olavs Hospital, Universitetssykehuset i Trondheim
🇳🇴Trondheim, Norway
Zuyderland Medisch Centrum
🇳🇱Heerlen, Netherlands
Erasmus Medisch Centrum
🇳🇱Rotterdam, Netherlands
University Clinical Center, Gdansk
🇵🇱Gdansk, Poland
Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland
🇵🇱Poznan, Poland
Clin.Hosp.Med.Univ.Marcinkowski in Poznan
🇵🇱Poznan, Poland
Hospital CUF Porto
🇵🇹Porto, Portugal
Centro Hospitalar Lisboa Norte Hospital Pulido Valente
🇵🇹Lisboa, Portugal
St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"
🇷🇺Chelyabinsk, Russian Federation
St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"
🇷🇺Kazan, Russian Federation
FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF
🇷🇺Moscow, Russian Federation
Wilgers Oncology Centre
🇿🇦Pretoria, South Africa
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF
🇷🇺Saint-Petersburg, Russian Federation
1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.
🇷🇺Saint-Petersburg, Russian Federation
Hospital Universitario de Cruces
🇪🇸Barakaldo (Vizcaya), Spain
Hospital Universitario Donostia
🇪🇸Donostia (Gipuzkoa), Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Virgen de la Victoria
🇪🇸Malaga, Spain
Hospital Duran i Reynals
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Clínico de Valencia
🇪🇸Valencia, Spain
Universitetssjukhuset, Linköping
🇸🇪Linköping, Sweden
Karolinska Univ. sjukhuset
🇸🇪Stockholm, Sweden
Skånes universitetssjukhus, Lund
🇸🇪Lund, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.
🇹🇷Eskisehir, Turkey
Dr.Suat Seren EAH
🇹🇷Izmir, Turkey
Western General Hospital
🇬🇧Edinburgh, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
The Royal Marsden Hospital
🇬🇧Sutton, United Kingdom
Sahlgrenska US, Göteborg
🇸🇪Göteborg, Sweden
Wythenshawe Hospital
🇬🇧Wythenshawe, United Kingdom
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Rocky Mountain Cancer Centers
🇺🇸Littleton, Colorado, United States
Comprehensive Cancer Centers of Nevada
🇺🇸Henderson, Nevada, United States
HOP HIA Saint-Anne
🇫🇷Toulon, France
Box Hill Hospital
🇦🇺Box Hill, Victoria, Australia
Rambam Medical Center
🇮🇱Haifa, Israel
Vivantes Netzwerk für Gesundheit GmbH
🇩🇪Berlin, Germany
UZ Leuven
🇧🇪Leuven, Belgium
Guy's Hospital
🇬🇧London, United Kingdom