Mesothelioma Clinical Trial
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
| Verified date | March 2019 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 545 |
| Est. completion date | August 31, 2018 |
| Est. primary completion date | March 16, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Instituto Medico Especializado Alexander Fleming | Ciudad Autónoma de Bs As | |
| Argentina | Sanatorio Güemes | Ciudad Autónoma de Bs As | |
| Argentina | Clínica Universitaria Reina Fabiola | Ciudad de Cordoba | |
| Australia | Box Hill Hospital | Box Hill | Victoria |
| Australia | The Prince Charles Hospital | Chermside | Queensland |
| Australia | Peninsula Haematology & Oncology | Frankston | Victoria |
| Australia | Austin Health | Heidelberg | Victoria |
| Australia | Sir Charles Gairdner Hospital | Nedlands | Western Australia |
| Australia | Perth Oncology | Perth | Western Australia |
| Australia | Mater Cancer Care Centre | South Brisbane | Queensland |
| Australia | Northern Cancer Institute | St Leonards | New South Wales |
| Australia | Calvary Mater Newcastle Hospital | Waratah | New South Wales |
| Australia | Border Onclogy Research | Wodonga | Victoria |
| Austria | LKH Leoben | Leoben | |
| Austria | AKH - Medical University of Vienna | Vienna | |
| Austria | Klinikum Wels - Grieskirchen GmbH | Wels | |
| Belgium | Brussels - UNIV Saint-Luc | Bruxelles | |
| Belgium | Edegem - UNIV UZ Antwerpen | Edegem | |
| Belgium | UNIV UZ Gent | Gent | |
| Belgium | UZ Leuven | Leuven | |
| Belgium | AZ Sint-Maarten | Mechelen | |
| Canada | QEII Health Sciences Centre (Dalhousie University) | Halifax | Nova Scotia |
| Canada | IUCPQ (Laval University) | Quebec | |
| Canada | Health Sciences North | Sudbury | Ontario |
| Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
| Chile | Centro Internacional de Estudios Clínicos - CIEC | Recoleta | |
| Chile | Orlandi Oncologia | Vitacura | |
| Croatia | University Clinic for Pulmonary Diseases | Zagreb | |
| Czechia | University Hospital Brno | Brno | |
| Czechia | University Hospital Olomouc | Olomouc | |
| Denmark | Rigshospitalet, København, Onkologisk afdeling | Købenahvn Ø | |
| Egypt | Clinical Research Center Alexandria | Alexandria | |
| Egypt | Medical Research Institute | Alexandria | |
| Egypt | Nasser Institute | Cairo | |
| Egypt | National Cancer Institute, Cairo University | Cairo | |
| France | CLI Bordeaux Nord Aquitaine | Bordeaux | |
| France | HOP Morvan | Brest | |
| France | HOP Côte de Nacre | Caen | |
| France | HOP Calmette | Lille | |
| France | HOP Nord | Marseille | |
| France | HOP Lyon Sud | Pierre-Bénite | |
| France | HOP HIA Saint-Anne | Toulon | |
| France | HOP Larrey | Toulouse | |
| France | INS Gustave Roussy | Villejuif | |
| Germany | Helios Klinikum Emil von Behring | Berlin | |
| Germany | Vivantes Netzwerk für Gesundheit GmbH | Berlin | |
| Germany | Klinik Schillerhöhe GmbH | Gerlingen | |
| Germany | Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH | Großhansdorf | |
| Germany | Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg | Heidelberg | |
| Germany | Universitätsklinikum des Saarlandes | Homburg/Saar | |
| Germany | Klinik, Löwenstein | Löwenstein | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Rabin Medical Center Beilinson | Petach Tikva | |
| Israel | Sourasky Medical Center | Tel-Aviv | |
| Italy | Azienda Ospedaliera Santi Antonio e Biagio e Cesare Arrigo | Alessandria | |
| Italy | Centro di riferimento Oncologico | Aviano (PN) | |
| Italy | Humanitas Gavazzeni | Bergamo | |
| Italy | Istituto Nazionale per la Ricerca sul Cancro | Genova | |
| Italy | Azienda Sanitaria Ospedale S. Luigi Gonzaga | Orbassano (TO) | |
| Italy | A.O.U. Senese Policlinico Santa Maria alle Scotte | Siena | |
| Japan | 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 | Japan Labour Health and Safety Organization Okayama Rosai Hospital | Okayama, Okayama | |
| Japan | Otemae Hospital | Osaka, Osaka | |
| Japan | Kindai University Hospital | Osaka, OsakaSayama | |
| Japan | Juntendo University Hospital | Tokyo, Bunkyo-ku | |
| Mexico | Centro Oncologico de Chihuahua | Chihuahua | |
| Mexico | Instituto Nacional de Cancerologia | Mexico | |
| Mexico | Centro Oncologico Estatal ISSEMYM | Toluca | |
| Netherlands | Medisch Spectrum Twente | Enschede | |
| Netherlands | Zuyderland Medisch Centrum | Heerlen | |
| Netherlands | Erasmus Medisch Centrum | Rotterdam | |
| Norway | Oslo Universitetssykehus HF, Radiumhospitalet | Oslo | |
| Norway | St. Olavs Hospital, Universitetssykehuset i Trondheim | Trondheim | |
| Poland | University Clinical Center, Gdansk | Gdansk | |
| Poland | Clin.Hosp.Med.Univ.Marcinkowski in Poznan | Poznan | |
| Poland | Greater PL Cent.Pulmo.&Thor.Surg.Eugenia&Janusz Zeyland | Poznan | |
| Poland | Onco.Cent. - Instit. of Maria Sklodowskiej-Curie | Warsaw | |
| Portugal | Centro Hospitalar Lisboa Norte Hospital Pulido Valente | Lisboa | |
| Portugal | Hospital CUF Porto | Porto | |
| Russian Federation | 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 | 1stPavlov St.Med.Univ.St.-Petersburg Res.Inst. | Saint-Petersburg | |
| Russian Federation | FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF | Saint-Petersburg | |
| Russian Federation | SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan | Ufa | |
| South Africa | Wilgers Oncology Centre | Pretoria | |
| Spain | Hospital Universitario de Cruces | Barakaldo (Vizcaya) | |
| Spain | Hospital Clínic de Barcelona | Barcelona | |
| Spain | Hospital Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitario Donostia | Donostia (Gipuzkoa) | |
| Spain | Hospital Duran i Reynals | L'Hospitalet de Llobregat | |
| Spain | Hospital Ramón y Cajal | Madrid | |
| Spain | Hospital Virgen de la Victoria | Malaga | |
| Spain | Hospital Virgen del Rocío | Sevilla | |
| Spain | Hospital Clínico de Valencia | Valencia | |
| Sweden | Sahlgrenska US, Göteborg | Göteborg | |
| Sweden | Universitetssjukhuset, Linköping | Linköping | |
| Sweden | Skånes universitetssjukhus, Lund | Lund | |
| Sweden | Karolinska Univ. sjukhuset | Stockholm | |
| Sweden | Akademiska sjukhuset | Uppsala | |
| Turkey | Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has. | Eskisehir | |
| Turkey | Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi | Istanbul | |
| Turkey | Dr.Suat Seren EAH | Izmir | |
| United Kingdom | Western General Hospital | Edinburgh | |
| United Kingdom | Beatson West of Scotland Cancer Centre | Glasgow | |
| United Kingdom | Leicester Royal Infirmary | Leicester | |
| United Kingdom | Guy's Hospital | London | |
| United Kingdom | The Royal Marsden Hospital | London | |
| United Kingdom | The Royal Marsden Hospital | Sutton | |
| United Kingdom | Wythenshawe Hospital | Wythenshawe | |
| United States | University of Alabama at Birmingham | Birmingham | Alabama |
| United States | Greenville Health System | Greenville | South Carolina |
| United States | Comprehensive Cancer Centers of Nevada | Henderson | Nevada |
| United States | The University of Texas MD Anderson Cancer Center | Houston | Texas |
| United States | Rocky Mountain Cancer Centers | Littleton | Colorado |
| United States | Texas Oncology - McAllen | McAllen | Texas |
| United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
| United States | Texas Oncology-San Antonio Northeast | San Antonio | Texas |
| United States | University of California San Francisco | San Francisco | California |
| United States | Cancer Care Northwest Centers, PS | Spokane Valley | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Croatia, Czechia, Denmark, Egypt, France, Germany, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russian Federation, South Africa, Spain, Sweden, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | 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. | 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) | |
| Secondary | Overall Survival (OS) | Overall survival was defined as the duration of time from randomization to time of death. This is the key secondary endpoint of the trial. |
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) | |
| Secondary | Objective Response According to Modified RECIST- Investigator Assessment | 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. |
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 | |
| Secondary | Disease Control According to Modified RECIST- Investigator Assessment | 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. |
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 |
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