Nintedanib (BIBF 1120) in Mesothelioma

NCT ID: NCT01907100

Last Updated: 2019-03-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 545 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-19
• Study Completion Date: 2018-08-31

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.

Conditions

Mesothelioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo + pemetrexed/cisplatin

Placebo controlled arm

Group Type: PLACEBO_COMPARATOR

Pemetrexed

Intervention Type: DRUG

backbone chemo

Cisplatin

Intervention Type: DRUG

backbone chemo

Placebo

Intervention Type: DRUG

Nintedanib matching placebo

Nintedanib 200mg + pemetrexed/cisplatin

Experimental arm

Group Type: EXPERIMENTAL

Nintedanib

Intervention Type: DRUG

triple kinase inhibitor; 200mg starting dose

Cisplatin

Intervention Type: DRUG

backbone chemo

Pemetrexed

Intervention Type: DRUG

backbone chemo

Interventions

Nintedanib

triple kinase inhibitor; 200mg starting dose

Intervention Type: DRUG

Pemetrexed

backbone chemo

Intervention Type: DRUG

Cisplatin

backbone chemo

Intervention Type: DRUG

Cisplatin

backbone chemo

Intervention Type: DRUG

Pemetrexed

backbone chemo

Intervention Type: DRUG

Placebo

Nintedanib matching placebo

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of California San Francisco

San Francisco, California, United States

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Comprehensive Cancer Centers of Nevada

Henderson, Nevada, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Greenville Health System

Greenville, South Carolina, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Texas Oncology - McAllen

McAllen, Texas, United States

Texas Oncology-San Antonio Northeast

San Antonio, Texas, United States

Cancer Care Northwest Centers, PS

Spokane Valley, Washington, United States

Sanatorio Güemes

Ciudad Autónoma de Bs As, , Argentina

Instituto Medico Especializado Alexander Fleming

Ciudad Autónoma de Bs As, , Argentina

Clínica Universitaria Reina Fabiola

Córdoba, , Argentina

Northern Cancer Institute

St Leonards, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

The Prince Charles Hospital

Chermside, Queensland, Australia

Mater Cancer Care Centre

South Brisbane, Queensland, Australia

Box Hill Hospital

Box Hill, Victoria, Australia

Peninsula Haematology & Oncology

Frankston, Victoria, Australia

Austin Health

Heidelberg, Victoria, Australia

Border Onclogy Research

Wodonga, Victoria, Australia

Sir Charles Gairdner Hospital

Nedlands, Western Australia, Australia

Perth Oncology

Perth, Western Australia, Australia

LKH Leoben

Leoben, , Austria

AKH - Medical University of Vienna

Vienna, , Austria

Klinikum Wels - Grieskirchen GmbH

Wels, , Austria

Brussels - UNIV Saint-Luc

Brussels, , Belgium

Edegem - UNIV UZ Antwerpen

Edegem, , Belgium

UNIV UZ Gent

Ghent, , Belgium

UZ Leuven

Leuven, , Belgium

AZ Sint-Maarten

Mechelen, , Belgium

QEII Health Sciences Centre (Dalhousie University)

Halifax, Nova Scotia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

IUCPQ (Laval University)

Québec, , Canada

Centro Internacional de Estudios Clínicos - CIEC

Recoleta, , Chile

Orlandi Oncologia

Vitacura, , Chile

University Clinic for Pulmonary Diseases

Zagreb, , Croatia

University Hospital Brno

Brno, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

Rigshospitalet, København, Onkologisk afdeling

Købenahvn Ø, , Denmark

Clinical Research Center Alexandria

Alexandria, , Egypt

Medical Research Institute

Alexandria, , Egypt

National Cancer Institute, Cairo University

Cairo, , Egypt

Nasser Institute

Cairo, , Egypt

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, , France

Vivantes Netzwerk für Gesundheit GmbH

Berlin, , Germany

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

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Klinik, Löwenstein

Löwenstein, , Germany

Rambam Medical Center

Haifa, , Israel

Rabin Medical Center Beilinson

Petah Tikva, , Israel

Sourasky Medical Center

Tel Aviv, , Israel

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, , 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

Japan Labour Health and Safety Organization Okayama Rosai Hospital

Okayama, Okayama, , Japan

Kindai University Hospital

Osaka, OsakaSayama, , Japan

Otemae Hospital

Osaka, Osaka, , Japan

Juntendo University Hospital

Tokyo, Bunkyo-ku, , Japan

Centro Oncologico de Chihuahua

Chihuahua City, , Mexico

Instituto Nacional de Cancerologia

México, , Mexico

Centro Oncologico Estatal ISSEMYM

Toluca, , Mexico

Medisch Spectrum Twente

Enschede, , Netherlands

Zuyderland Medisch Centrum

Heerlen, , Netherlands

Erasmus Medisch Centrum

Rotterdam, , Netherlands

Oslo Universitetssykehus HF, Radiumhospitalet

Oslo, , Norway

St. Olavs Hospital, Universitetssykehuset i Trondheim

Trondheim, , Norway

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, , Poland

Centro Hospitalar Lisboa Norte Hospital Pulido Valente

Lisbon, , Portugal

Hospital CUF Porto

Porto, , Portugal

St.Budg.Heal.Inst."Chelyabinsk Reg.Clin.Cen.Onc&Nucl.Med"

Chelyabinsk, , Russia

St.Auton.Heal.Inst."Rep.Clin.Onc.Disp.of MoH of Rep. Tatarstan"

Kazan', , Russia

FSBI "N.N Blokhin Med.Res.Cent.Onc."MoH of RF

Moscow, , Russia

1stPavlov St.Med.Univ.St.-Petersburg Res.Inst.

Saint Petersburg, , Russia

FSBI "N.N. Petrov National Medical Research Center of Oncology" of MoH of RF

Saint Petersburg, , Russia

SBI HC-Rep.Clin.Onc.Disp.MoH.Rep.Bashkortostan

Ufa, , Russia

Wilgers Oncology Centre

Pretoria, , South Africa

Hospital Universitario de Cruces

Barakaldo (Vizcaya), , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Clínic de Barcelona

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

Málaga, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital Clínico de Valencia

Valencia, , Spain

Sahlgrenska US, Göteborg

Gothenburg, , Sweden

Universitetssjukhuset, Linköping

Linköping, , Sweden

Skånes universitetssjukhus, Lund

Lund, , Sweden

Karolinska Univ. sjukhuset

Stockholm, , Sweden

Akademiska sjukhuset

Uppsala, , Sweden

Eskisehir Osmangazi Üni. Sag. Uygulama ve Arastirma Has.

Eskişehir, , Turkey (Türkiye)

Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi

Istanbul, , Turkey (Türkiye)

Dr.Suat Seren EAH

Izmir, , Turkey (Türkiye)

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 Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Canada; Chile; Croatia; Czechia; Denmark; Egypt; France; Germany; Israel; Italy; Japan; Mexico; Netherlands; Norway; Poland; Portugal; Russia; South Africa; Spain; Sweden; Turkey (Türkiye); United Kingdom

References

Scagliotti GV, Gaafar R, Nowak AK, Nakano T, van Meerbeeck J, Popat S, Vogelzang NJ, Grosso F, Aboelhassan R, Jakopovic M, Ceresoli GL, Taylor P, Orlandi F, Fennell DA, Novello S, Scherpereel A, Kuribayashi K, Cedres S, Sorensen JB, Pavlakis N, Reck M, Velema D, von Wangenheim U, Kim M, Barrueco J, Tsao AS. Nintedanib in combination with pemetrexed and cisplatin for chemotherapy-naive patients with advanced malignant pleural mesothelioma (LUME-Meso): a double-blind, randomised, placebo-controlled phase 3 trial. Lancet Respir Med. 2019 Jul;7(7):569-580. doi: 10.1016/S2213-2600(19)30139-0. Epub 2019 May 15.

Reference Type: DERIVED

PMID: 31103412 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2012-005201-48

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1199.93

Identifier Type: -

Identifier Source: org_study_id