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Nintedanib (BIBF 1120) in Mesothelioma

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ClinicalTrials.gov Identifier: NCT01907100
Recruitment Status : Recruiting
First Posted : July 24, 2013
Last Update Posted : January 10, 2018
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Mesothelioma Drug: Nintedanib Drug: Pemetrexed Drug: Cisplatin Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 537 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: LUME-Meso: Double Blind, Randomised, Multicentre, Phase II/III Study of Nintedanib in Combination With Pemetrexed / Cisplatin Followed by Continuing Nintedanib Monotherapy Versus Placebo in Combination With Pemetrexed / Cisplatin Followed by Continuing Placebo Monotherapy for the Treatment of Patients With Unresectable Malignant Pleural Mesothelioma
Actual Study Start Date : September 19, 2013
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : October 30, 2019

Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: Placebo + pemetrexed/cisplatin
Placebo controlled arm
Drug: Pemetrexed
backbone chemo
Drug: Cisplatin
backbone chemo
Drug: Placebo
Nitedanib matching placebo
Experimental: Nintedanib 200mg + pemetrexed/cisplastin
Experimental arm
Drug: Nintedanib
triple kinase inhibitor; 200mg starting dose
Drug: Cisplatin
backbone chemo
Drug: Pemetrexed
backbone chemo

Outcome Measures

Primary Outcome Measures :
  1. Progression free survival measured from the time of randomisation to the time of disease progression or death of any cause, whichever occurs earlier [ Time Frame: up to 3 years ]

Secondary Outcome Measures :
  1. Overall survival measured from the time of randomisation to the time of death of any cause [ Time Frame: up to 3 years ]
  2. Objective response according to modified RECIST analysed by objective response rate [ Time Frame: up to 3 years ]
  3. Disease control according to modified RECIST analysed by disease control rate [ Time Frame: up to 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  • Histologically confirmed malignant pleural mesothelioma (MPM) (Epithelioid or biphasic subtype for Phase II patients; epithelioid subtype only for Phase III patients)
  • Life expectancy of at least 3 months in the opinion of the investigator
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1
  • Measurable disease according to modified RECIST (Response Evaluation Criteria In Solid Tumours) criteria

Exclusion criteria:

  • Previous systemic chemotherapy for MPM
  • Prior treatment with nintedanib or any other prior line of therapy
  • Phase II patients with sarcomatoid subtype MPM or Phase III patients with biphasic or sarcomatoid subtype MPM
  • Patients with symptomatic neuropathy
  • Radiotherapy (except extremities) within 3 months prior to baseline imaging
  • Active brain metastases (e.g. stable for < 4 weeks)
  • Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM
  • Significant cardiovascular diseases
  • Inadequate hematologic, renal, or hepatic function
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907100

Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

  Hide Study Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States, 94115
United States, Colorado
Rocky Mountain Cancer Centers Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Nevada
Comprehensive Cancer Centers of Nevada- Peak Office Recruiting
Henderson, Nevada, United States, 89052
United States, Pennsylvania
University of Pittsburgh Medical Center Terminated
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Greenville Health System Recruiting
Greenville, South Carolina, United States, 29615
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Texas Oncology - McAllen Recruiting
McAllen, Texas, United States, 78503
Texas Oncology-San Antonio Northeast Recruiting
San Antonio, Texas, United States, 78217
United States, Washington
Cancer Care Northwest Centers, PS Recruiting
Spokane Valley, Washington, United States, 99216
Sanatorio Güemes Recruiting
Ciudad Autónoma de Bs As, Argentina, C1180AAX
Instituto Medico Especializado Alexander Fleming Recruiting
Ciudad Autónoma de Bs As, Argentina, C1426ANZ
Clínica Universitaria Reina Fabiola Recruiting
Ciudad de Cordoba, Argentina, X5004FHP
Australia, New South Wales
Northern Cancer Institute Recruiting
St Leonards, New South Wales, Australia, 2065
Calvary Mater Newcastle Hospital Recruiting
Waratah, New South Wales, Australia, 2298
Australia, Queensland
The Prince Charles Hospital Recruiting
Chermside, Queensland, Australia, 4032
Mater Cancer Care Centre Recruiting
South Brisbane, Queensland, Australia, 4101
Australia, Victoria
Box Hill Hospital Recruiting
Box Hill, Victoria, Australia, 3128
Peninsula Haematology & Oncology Recruiting
Frankston, Victoria, Australia, 3199
Austin Health Recruiting
Heidelberg, Victoria, Australia, 3084
Border Onclogy Research Recruiting
Wodonga, Victoria, Australia, 3690
Australia, Western Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Western Australia, Australia, 6009
Perth Oncology Recruiting
Perth, Western Australia, Australia, 6000
LKH Leoben Recruiting
Leoben, Austria, 8700
Klinikum Wels - Grieskirchen GmbH Recruiting
Wels, Austria, 4600
Brussels - UNIV St-Luc Recruiting
Bruxelles, Belgium, 1200
Edegem - UNIV UZ Antwerpen Recruiting
Edegem, Belgium, 2650
UNIV UZ Gent Recruiting
Gent, Belgium, 9000
UZ Leuven Recruiting
Leuven, Belgium, 3000
Mechelen - HOSP St-Maarten Recruiting
Mechelen, Belgium, 2800
Canada, Nova Scotia
QEII Health Sciences Centre (Dalhousie University) Recruiting
Halifax, Nova Scotia, Canada, B3H 1V7
Canada, Ontario
Health Sciences North Recruiting
Sudbury, Ontario, Canada, P3E 5J1
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
IUCPQ (Laval University) Recruiting
Quebec, Canada, GLV 4G5
Centro Internacional de Estudios Clínicos - CIEC Recruiting
Recoleta, Chile, 8420383
Orlandi Oncologia Recruiting
Vitacura, Chile, 7630372
Clinical Hospital Osijek Recruiting
Osijek, Croatia, 31000
University Clinic for Pulmonary Diseases Recruiting
Zagreb, Croatia, 10000
University Hospital Brno Recruiting
Brno, Czechia, 625 00
University Hospital Olomouc Recruiting
Olomouc, Czechia, 779 00
Rigshospitalet, København, Onkologisk afd Recruiting
Købenahvn Ø, Denmark, 2100
Clinical Research Center Alexandria Recruiting
Alexandria, Egypt, 21131
Medical Research Institute Recruiting
Alexandria, Egypt, 21648
National Cancer Institute, Cairo University Recruiting
Cairo, Egypt, 11796
Nasser Institute Recruiting
Cairo, Egypt, 12655
CLI Bordeaux Nord Aquitaine Recruiting
Bordeaux, France, 33000
HOP Morvan Recruiting
Brest, France, 29609
HOP Côte de Nacre Recruiting
Caen, France, 14033
HOP Calmette Recruiting
Lille, France, 59000
HOP Dupuytren Recruiting
Limoges, France, 87042
HOP Nord Recruiting
Marseille, France, 13015
HOP Lyon Sud Recruiting
Pierre-Bénite, France, 69230
HOP HIA Saint-Anne Recruiting
Toulon, France, 83800
HOP Larrey Completed
Toulouse, France, 31059
INS Gustave Roussy Recruiting
Villejuif, France, 94805
Vivantes Netzwerk für Gesundheit GmbH Recruiting
Berlin, Germany, 12351
HELIOS Klinikum Emil von Behring GmbH Recruiting
Berlin, Germany, 14165
Klinik Schillerhöhe, Gerlingen Recruiting
Gerlingen, Germany, 70839
Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH Recruiting
Großhansdorf, Germany, 22927
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Recruiting
Heidelberg, Germany, 69126
Universitätsklinikum des Saarlandes Recruiting
Homburg/Saar, Germany, 66421
Klinik, Löwenstein Recruiting
Löwenstein, Germany, 74245
Soroka Univ. Medical Center Recruiting
Beer Sheva, Israel, 84101
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Meir Medical Center Recruiting
Kfar-Saba, Israel, 4441003
Rabin Medical Center Beilinson Recruiting
Petach Tikva, Israel, 49100
Sourasky Medical Center Recruiting
Tel-Aviv, Israel, 64239
Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy, 15121
Humanitas Gavazzeni Recruiting
Bergamo, Italy, 24125
Istituto Nazionale per la Ricerca sul Cancro Recruiting
Genova, Italy, 16132
A.O. San Gerardo di Monza Recruiting
Monza, Italy, 20052
Azienda Sanitaria Ospedale S. Luigi Gonzaga Recruiting
Orbassano (TO), Italy, 10043
A.O. S.Maria degli Angeli Recruiting
Pordenone, Italy, 33170
A.O.U. Senese Policlinico Santa Maria alle Scotte Recruiting
Siena, Italy, 53100
Ospedale S. Giuseppe Moscati Recruiting
Statte (TA), Italy, 74010
University Hospital of Occupational and Environmental Health Recruiting
Fukuoka, Kitakyushu, Japan, 807-8556
Hokkaido University Hospital Recruiting
Hokkaido, Sapporo, Japan, 060-8648
Hyogo Prefectural Amagasaki General Medical Center Recruiting
Hyogo, Amagasaki, Japan, 660-8550
National Hospital Organization Himeji Medical Center Recruiting
Hyogo, Himeji, Japan, 670-8520
Hyogo College of Medicine Hospital Recruiting
Hyogo, Nishinomiya, Japan, 663-8501
Yokosuka Kyosai Hospital Recruiting
Kanagawa , Yokosuka, Japan, 238-8558
Japan Labour Health and Safety Organization Okayama Rosai Hospital Recruiting
Okayama, Okayama, Japan, 702-8055
Kindai University Hospital Recruiting
Osaka, OsakaSayama, Japan, 589-8511
Otemae Hospital Recruiting
Osaka, Osaka, Japan, 540-0008
Juntendo University Hospital Recruiting
Tokyo, Bunkyo-ku, Japan, 113-8431
Centro Oncologico de Chihuahua Recruiting
Chihuahua, Mexico, 31217
Instituto Nacional de Cancerologia Recruiting
Mexico, Mexico, 14080
Centro Oncologico Estatal ISSEMYM Recruiting
Toluca, Mexico, 50180
Medisch Spectrum Twente Recruiting
Enschede, Netherlands, 7513 ER
Zuyderland Medisch Centrum Recruiting
Heerlen, Netherlands, 6419 PC
Erasmus Medisch Centrum Recruiting
Rotterdam, Netherlands, 3015 CE
Oslo Universitetssykehus HF, Radiumhospitalet Recruiting
Oslo, Norway, N-0310
St. Olavs Hospital, Universitetssykehuset i Trondheim Recruiting
Trondheim, Norway, N-7006
University Clinical Center, Gdansk Recruiting
Gdansk, Poland, 80-952
Clin. Hosp. of Univ. of Med. Sciences Recruiting
Poznan, Poland, 60-569
Wielkopolski Center Pulmonology+Tuberculosis P-III, Poznan Recruiting
Poznan, Poland, 60-569
Oncol Centre M Sklodowska-Curie, Dept of Lung & Chest Cancer Recruiting
Warsaw, Poland, 02-781
Centro Hospitalar Lisboa Norte Hospital Pulido Valente Recruiting
Lisboa, Portugal, 1769-001
Hospital CUF Porto Recruiting
Porto, Portugal, 4100-180
IPO Porto Francisco Gentil, EPE Recruiting
Porto, Portugal, 4200-072
CHTAD, EPE - Hospital São Pedro de Vila Real Recruiting
Vila Real, Portugal, 5000-508
Russian Federation
FGBUZ "Chelyabinsk Reg. Oncology Dispensary";Chemotherpy Dep Recruiting
Chelyabinsk, Russian Federation, 454087
Republic Clinical Oncology Dispensary, Dept. Chemotherapy Recruiting
Kazan, Russian Federation, 420029
First Pavlov State Medical University Saint Petersburg Recruiting
Saint-Petersburg, Russian Federation, 197022
FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF Recruiting
Saint-Petersburg, Russian Federation, 197758
Republican Clinical Oncology Center Ufa Recruiting
Ufa, Russian Federation, 450054
South Africa
Wilgers Oncology Centre Recruiting
Pretoria, South Africa, 0041
Merc Oncology Recruiting
Pretoria, South Africa, 0157
Hospital Universitario de Cruces Recruiting
Barakaldo (Vizcaya), Spain, 48903
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Hospital Clínic de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Universitario Donostia Recruiting
Donostia (Gipuzkoa), Spain, 20080
Hospital Duran i Reynals Recruiting
L'Hospitalet de Llobregat, Spain, 08907
Hospital Ramón y Cajal Recruiting
Madrid, Spain, 28034
Hospital Virgen de la Victoria Recruiting
Malaga, Spain, 29010
CS Parc Taulí Recruiting
Sabadell (Barcelona), Spain, 08208
Hospital Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Hospital Clínico de Valencia Recruiting
Valencia, Spain, 46010
Sahlgrenska US, Göteborg Recruiting
Göteborg, Sweden, 413 45
Universitetssjukhuset, Linköping Recruiting
Linköping, Sweden, 581 85
Skånes universitetssjukhus Recruiting
Lund, Sweden, 221 85
Karolinska Univ. sjukhuset Recruiting
Stockholm, Sweden, 171 76
Akademiska sjukhuset Recruiting
Uppsala, Sweden, 751 85
Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has. Recruiting
Eskisehir, Turkey, 26950
Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi Recruiting
Istanbul, Turkey, 34899
Dr.Suat Seren EAH Recruiting
Izmir, Turkey, 35120
United Kingdom
Western General Hospital Completed
Edinburgh, United Kingdom, EH4 2XU
The Beatson West of Scotland Cancer Centre Recruiting
Glasgow, United Kingdom, G12 0YN
Leicester Royal Infirmary Recruiting
Leicester, United Kingdom, LE1 5WW
Guy's Hospital Recruiting
London, United Kingdom, SE1 9RT
The Royal Marsden Hospital Recruiting
London, United Kingdom, SW3 6JJ
University Hospital of North Tees Recruiting
Stockton-on-Tees, United Kingdom, TS19 8PE
The Royal Marsden Hospital Recruiting
Sutton, United Kingdom, SM2 5PT
Wythenshawe Hospital Recruiting
Wythenshawe, United Kingdom, M23 9LT
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information

Additional Information:
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01907100     History of Changes
Other Study ID Numbers: 1199.93
2012-005201-48 ( EudraCT Number )
First Posted: July 24, 2013    Key Record Dates
Last Update Posted: January 10, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors