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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01907100
Other study ID # 1199.93
Secondary ID 2012-005201-48
Status Terminated
Phase Phase 2/Phase 3
First received
Last updated
Start date September 19, 2013
Est. completion date August 31, 2018

Study information

Verified date March 2019
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nintedanib
triple kinase inhibitor; 200mg starting dose
Pemetrexed
backbone chemo
Cisplatin
backbone chemo
Cisplatin
backbone chemo
Pemetrexed
backbone chemo
Placebo
Nintedanib matching placebo

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

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, 

Outcome

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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