Nintedanib (BIBF 1120) in Mesothelioma
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01907100 |
|
Recruitment Status :
Completed
First Posted : July 24, 2013
Last Update Posted : September 11, 2018
|
Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
- Study Details
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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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 545 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 |
| Actual Primary Completion Date : | March 16, 2018 |
| Actual Study Completion Date : | August 28, 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Mesothelioma
| 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 |
Primary Outcome Measures :
- 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 :
- Overall survival measured from the time of randomisation to the time of death of any cause [ Time Frame: up to 3 years ]
- Objective response according to modified RECIST analysed by objective response rate [ Time Frame: up to 3 years ]
- Disease control according to modified RECIST analysed by disease control rate [ Time Frame: up to 3 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
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
Hide Study Locations
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35249 | |
| United States, California | |
| University of California San Francisco | |
| San Francisco, California, United States, 94115 | |
| United States, Colorado | |
| Rocky Mountain Cancer Centers | |
| Littleton, Colorado, United States, 80120-4413 | |
| United States, Nevada | |
| Comprehensive Cancer Centers of Nevada- Peak Office | |
| Henderson, Nevada, United States, 89052 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15232 | |
| United States, South Carolina | |
| Greenville Health System | |
| Greenville, South Carolina, United States, 29615 | |
| United States, Texas | |
| The University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Texas Oncology - McAllen | |
| McAllen, Texas, United States, 78503 | |
| Texas Oncology-San Antonio Northeast | |
| San Antonio, Texas, United States, 78217 | |
| United States, Washington | |
| Cancer Care Northwest Centers, PS | |
| Spokane Valley, Washington, United States, 99216 | |
| Argentina | |
| Sanatorio Güemes | |
| Ciudad Autónoma de Bs As, Argentina, C1180AAX | |
| Instituto Medico Especializado Alexander Fleming | |
| Ciudad Autónoma de Bs As, Argentina, C1426ANZ | |
| Clínica Universitaria Reina Fabiola | |
| Ciudad de Cordoba, Argentina, X5004FHP | |
| Australia, New South Wales | |
| Northern Cancer Institute | |
| St Leonards, New South Wales, Australia, 2065 | |
| Calvary Mater Newcastle Hospital | |
| Waratah, New South Wales, Australia, 2298 | |
| Australia, Queensland | |
| The Prince Charles Hospital | |
| Chermside, Queensland, Australia, 4032 | |
| Mater Cancer Care Centre | |
| South Brisbane, Queensland, Australia, 4101 | |
| Australia, Victoria | |
| Box Hill Hospital | |
| Box Hill, Victoria, Australia, 3128 | |
| Peninsula Haematology & Oncology | |
| Frankston, Victoria, Australia, 3199 | |
| Austin Health | |
| Heidelberg, Victoria, Australia, 3084 | |
| Border Onclogy Research | |
| Wodonga, Victoria, Australia, 3690 | |
| Australia, Western Australia | |
| Sir Charles Gairdner Hospital | |
| Nedlands, Western Australia, Australia, 6009 | |
| Perth Oncology | |
| Perth, Western Australia, Australia, 6000 | |
| Austria | |
| LKH Leoben | |
| Leoben, Austria, 8700 | |
| Klinikum Wels - Grieskirchen GmbH | |
| Wels, Austria, 4600 | |
| Medical Universitay Clinic Vienna | |
| Wien, Austria, 1090 | |
| Belgium | |
| Brussels - UNIV Saint-Luc | |
| Bruxelles, Belgium, 1200 | |
| Edegem - UNIV UZ Antwerpen | |
| Edegem, Belgium, 2650 | |
| UNIV UZ Gent | |
| Gent, Belgium, 9000 | |
| UZ Leuven | |
| Leuven, Belgium, 3000 | |
| AZ Sint-Maarten | |
| Mechelen, Belgium, 2800 | |
| Canada, Nova Scotia | |
| QEII Health Sciences Centre (Dalhousie University) | |
| Halifax, Nova Scotia, Canada, B3H 1V7 | |
| Canada, Ontario | |
| Health Sciences North | |
| Sudbury, Ontario, Canada, P3E 5J1 | |
| Princess Margaret Cancer Centre | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Canada | |
| IUCPQ (Laval University) | |
| Quebec, Canada, GLV 4G5 | |
| Chile | |
| Centro Internacional de Estudios Clínicos - CIEC | |
| Recoleta, Chile, 8420383 | |
| Orlandi Oncologia | |
| Vitacura, Chile, 7630372 | |
| Croatia | |
| University Clinic for Pulmonary Diseases | |
| Zagreb, Croatia, 10000 | |
| Czechia | |
| University Hospital Brno | |
| Brno, Czechia, 625 00 | |
| University Hospital Olomouc | |
| Olomouc, Czechia, 779 00 | |
| Denmark | |
| Rigshospitalet, København, Onkologisk afdeling | |
| Købenahvn Ø, Denmark, 2100 | |
| Egypt | |
| Clinical Research Center Alexandria | |
| Alexandria, Egypt, 21131 | |
| Medical Research Institute | |
| Alexandria, Egypt, 21648 | |
| National Cancer Institute, Cairo University | |
| Cairo, Egypt, 11796 | |
| Nasser Institute | |
| Cairo, Egypt, 12655 | |
| France | |
| CLI Bordeaux Nord Aquitaine | |
| Bordeaux, France, 33000 | |
| HOP Morvan | |
| Brest, France, 29609 | |
| HOP Côte de Nacre | |
| Caen, France, 14033 | |
| HOP Calmette | |
| Lille, France, 59000 | |
| HOP Nord | |
| Marseille, France, 13015 | |
| HOP Lyon Sud | |
| Pierre-Bénite, France, 69230 | |
| HOP HIA Saint-Anne | |
| Toulon, France, 83800 | |
| HOP Larrey | |
| Toulouse, France, 31059 | |
| INS Gustave Roussy | |
| Villejuif, France, 94805 | |
| Germany | |
| Vivantes Netzwerk für Gesundheit GmbH | |
| Berlin, Germany, 12351 | |
| Helios Klinikum Emil von Behring | |
| Berlin, Germany, 14165 | |
| Klinik Schillerhöhe GmbH | |
| Gerlingen, Germany, 70839 | |
| Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | |
| Großhansdorf, Germany, 22927 | |
| Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | |
| Heidelberg, Germany, 69126 | |
| Universitätsklinikum des Saarlandes | |
| Homburg/Saar, Germany, 66421 | |
| Klinik, Löwenstein | |
| Löwenstein, Germany, 74245 | |
| Israel | |
| Rambam Medical Center | |
| Haifa, Israel, 31096 | |
| Rabin Medical Center Beilinson | |
| Petach Tikva, Israel, 49100 | |
| Sourasky Medical Center | |
| Tel-Aviv, Israel, 64239 | |
| Italy | |
| Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | |
| Alessandria, Italy, 15121 | |
| Centro di riferimento Oncologico | |
| Aviano (PN), Italy, 33081 | |
| Humanitas Gavazzeni | |
| Bergamo, Italy, 24125 | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genova, Italy, 16132 | |
| Azienda Sanitaria Ospedale S. Luigi Gonzaga | |
| Orbassano (TO), Italy, 10043 | |
| A.O.U. Senese Policlinico Santa Maria alle Scotte | |
| Siena, Italy, 53100 | |
| Japan | |
| University Hospital of Occupational and Environmental Health | |
| Fukuoka, Kitakyushu, Japan, 807-8556 | |
| Hyogo Prefectural Amagasaki General Medical Center | |
| Hyogo, Amagasaki, Japan, 660-8550 | |
| Hyogo College of Medicine Hospital | |
| Hyogo, Nishinomiya, Japan, 663-8501 | |
| Yokosuka Kyosai Hospital | |
| Kanagawa , Yokosuka, Japan, 238-8558 | |
| Japan Labour Health and Safety Organization Okayama Rosai Hospital | |
| Okayama, Okayama, Japan, 702-8055 | |
| Kindai University Hospital | |
| Osaka, OsakaSayama, Japan, 589-8511 | |
| Otemae Hospital | |
| Osaka, Osaka, Japan, 540-0008 | |
| Juntendo University Hospital | |
| Tokyo, Bunkyo-ku, Japan, 113-8431 | |
| Mexico | |
| Centro Oncologico de Chihuahua | |
| Chihuahua, Mexico, 31217 | |
| Instituto Nacional de Cancerologia | |
| Mexico, Mexico, 14080 | |
| Centro Oncologico Estatal ISSEMYM | |
| Toluca, Mexico, 50180 | |
| Netherlands | |
| Medisch Spectrum Twente | |
| Enschede, Netherlands, 7513 ER | |
| Zuyderland Medisch Centrum | |
| Heerlen, Netherlands, 6419 PC | |
| Erasmus Medisch Centrum | |
| Rotterdam, Netherlands, 3015 CE | |
| Norway | |
| Oslo Universitetssykehus HF, Radiumhospitalet | |
| Oslo, Norway, N-0310 | |
| St. Olavs Hospital, Universitetssykehuset i Trondheim | |
| Trondheim, Norway, N-7006 | |
| Poland | |
| University Clinical Center, Gdansk | |
| Gdansk, Poland, 80-952 | |
| Clin.Hosp.Med.Univ.Marcinkowski in Poznan | |
| Poznan, Poland, 60-569 | |
| Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland | |
| Poznan, Poland, 60-569 | |
| Onco.Cent. - Instit. of Maria Sklodowskiej-Curie | |
| Warsaw, Poland, 02-781 | |
| Portugal | |
| Centro Hospitalar Lisboa Norte Hospital Pulido Valente | |
| Lisboa, Portugal, 1769-001 | |
| Hospital CUF Porto | |
| Porto, Portugal, 4100-180 | |
| Russian Federation | |
| St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med" | |
| Chelyabinsk, Russian Federation, 454087 | |
| St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan" | |
| Kazan, Russian Federation, 420029 | |
| FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF | |
| Moscow, Russian Federation, 115478 | |
| 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst. | |
| Saint-Petersburg, Russian Federation, 197022 | |
| FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF | |
| Saint-Petersburg, Russian Federation, 197758 | |
| SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan | |
| Ufa, Russian Federation, 450054 | |
| South Africa | |
| Wilgers Oncology Centre | |
| Pretoria, South Africa, 0041 | |
| Spain | |
| Hospital Universitario de Cruces | |
| Barakaldo (Vizcaya), Spain, 48903 | |
| Hospital Vall d'Hebron | |
| Barcelona, Spain, 08035 | |
| Hospital Clínic de Barcelona | |
| Barcelona, Spain, 08036 | |
| Hospital Universitario Donostia | |
| Donostia (Gipuzkoa), Spain, 20080 | |
| Hospital Duran i Reynals | |
| L'Hospitalet de Llobregat, Spain, 08907 | |
| Hospital Ramón y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital Virgen de la Victoria | |
| Malaga, Spain, 29010 | |
| Hospital Virgen del Rocío | |
| Sevilla, Spain, 41013 | |
| Hospital Clínico de Valencia | |
| Valencia, Spain, 46010 | |
| Sweden | |
| Sahlgrenska US, Göteborg | |
| Göteborg, Sweden, 413 45 | |
| Universitetssjukhuset, Linköping | |
| Linköping, Sweden, 581 85 | |
| Skånes universitetssjukhus, Lund | |
| Lund, Sweden, 221 85 | |
| Karolinska Univ. sjukhuset | |
| Stockholm, Sweden, 171 76 | |
| Akademiska sjukhuset | |
| Uppsala, Sweden, 751 85 | |
| Turkey | |
| Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has. | |
| Eskisehir, Turkey, 26950 | |
| Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi | |
| Istanbul, Turkey, 34899 | |
| Dr.Suat Seren EAH | |
| Izmir, Turkey, 35120 | |
| United Kingdom | |
| Western General Hospital | |
| Edinburgh, United Kingdom, EH4 2XU | |
| Beatson West of Scotland Cancer Centre | |
| Glasgow, United Kingdom, G12 0YN | |
| Leicester Royal Infirmary | |
| Leicester, United Kingdom, LE1 5WW | |
| Guy's Hospital | |
| London, United Kingdom, SE1 9RT | |
| The Royal Marsden Hospital | |
| London, United Kingdom, SW3 6JJ | |
| The Royal Marsden Hospital | |
| Sutton, United Kingdom, SM2 5PT | |
| Wythenshawe Hospital | |
| Wythenshawe, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
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: | September 11, 2018 |
| Last Verified: | September 2018 |
Additional relevant MeSH terms:
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial Nintedanib |
Cisplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |