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Eligibility
for people ages 18 years and up
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

Description

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.

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

Keywords

Mesothelioma Nintedanib Cisplatin Pemetrexed

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Boehringer Ingelheim Investigational Site accepting new patients
    San Francisco, California, USA
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Birmingham, Alabama, USA
  • Boehringer Ingelheim Investigational Site accepting new patients
    Colorado Springs, Colorado, USA
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Edina, Minnesota, USA
  • Boehringer Ingelheim Investigational Site accepting new patients
    Henderson, Nevada, USA
  • Boehringer Ingelheim Investigational Site terminated
    Pittsburgh, Pennsylvania, USA
  • Boehringer Ingelheim Investigational Site accepting new patients
    Greenville, South Carolina, USA
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Houston, Texas, USA
  • Boehringer Ingelheim Investigational Site accepting new patients
    McAllen, Texas, USA
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    San Antonio, Texas, USA
  • Boehringer Ingelheim Investigational Site accepting new patients
    Spokane Valley, Washington, USA
  • Boehringer Ingelheim Investigational Site accepting new patients
    Capital Federal, Argentina
  • Boehringer Ingelheim Investigational Site accepting new patients
    Ciudad Autónoma de Bs As, Argentina
  • Boehringer Ingelheim Investigational Site accepting new patients
    Ciudad de Cordoba, Argentina
  • Boehringer Ingelheim Investigational Site accepting new patients
    St Leonards, New South Wales, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Waratah, New South Wales, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Chermside, Queensland, Australia
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    South Brisbane, Queensland, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Box Hill, Victoria, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Frankston, Victoria, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Heidelberg, Victoria, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Wodonga, Victoria, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Nedlands, Western Australia, Australia
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Perth, Western Australia, Australia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Leoben, Austria
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Wels, Austria
  • Boehringer Ingelheim Investigational Site accepting new patients
    Bruxelles, Belgium
  • Boehringer Ingelheim Investigational Site accepting new patients
    Edegem, Belgium
  • Boehringer Ingelheim Investigational Site accepting new patients
    Gent, Belgium
  • Boehringer Ingelheim Investigational Site accepting new patients
    Leuven, Belgium
  • Boehringer Ingelheim Investigational Site accepting new patients
    Mechelen, Belgium
  • Boehringer Ingelheim Investigational Site accepting new patients
    Halifax, Nova Scotia, Canada
  • Boehringer Ingelheim Investigational Site accepting new patients
    Sudbury, Ontario, Canada
  • Boehringer Ingelheim Investigational Site accepting new patients
    Toronto, Ontario, Canada
  • Boehringer Ingelheim Investigational Site accepting new patients
    Quebec, Canada
  • Boehringer Ingelheim Investigational Site accepting new patients
    Recoleta, Chile
  • Boehringer Ingelheim Investigational Site accepting new patients
    Vitacura, Chile
  • Boehringer Ingelheim Investigational Site accepting new patients
    Osijek, Croatia
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Pula, Croatia
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Split, Croatia
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Zagreb, Croatia
  • Boehringer Ingelheim Investigational Site accepting new patients
    Brno, Czech Republic
  • Boehringer Ingelheim Investigational Site accepting new patients
    Olomouc, Czech Republic
  • Boehringer Ingelheim Investigational Site accepting new patients
    Købenahvn Ø, Denmark
  • Boehringer Ingelheim Investigational Site accepting new patients
    Alexandria, Egypt
  • Boehringer Ingelheim Investigational Site accepting new patients
    Cairo, Egypt
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Cairo, Egypt
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Dakahlia, Egypt
  • Boehringer Ingelheim Investigational Site accepting new patients
    Bordeaux, France
  • Boehringer Ingelheim Investigational Site accepting new patients
    Brest, France
  • Boehringer Ingelheim Investigational Site accepting new patients
    Caen, France
  • Boehringer Ingelheim Investigational Site accepting new patients
    Lille, France
  • Boehringer Ingelheim Investigational Site accepting new patients
    Limoges Cedex, France
  • Boehringer Ingelheim Investigational Site accepting new patients
    Toulon Cedex 9, France
  • Boehringer Ingelheim Investigational Site completed
    Toulouse Cedex 9, France
  • Boehringer Ingelheim Investigational Site accepting new patients
    Berlin, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    Gerlingen, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    Großhansdorf, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    Heidelberg, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    Homburg/Saar, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    Löwenstein, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    München, Germany
  • Boehringer Ingelheim Investigational Site accepting new patients
    Beer Sheva, Israel
  • Boehringer Ingelheim Investigational Site accepting new patients
    Haifa, Israel
  • Boehringer Ingelheim Investigational Site accepting new patients
    Kfar-Saba, Israel
  • Boehringer Ingelheim Investigational Site accepting new patients
    Petach Tikva, Israel
  • Boehringer Ingelheim Investigational Site accepting new patients
    Tel-Aviv, Israel
  • Boehringer Ingelheim Investigational Site accepting new patients
    Alessandria, Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Bergamo, Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Genova, Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Monza, Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Orbassano (TO), Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Pordenone, Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Siena, Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Statte (TA), Italy
  • Boehringer Ingelheim Investigational Site accepting new patients
    Fukuoka, Kitakyushu, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Hokkaido, Sapporo, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Hyogo, Amagasaki, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Hyogo, Himeji, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Hyogo, Nishinomiya, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Kanagawa , Yokosuka, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Okayama, Okayama, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Osaka, OsakaSayama, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Tokyo, Bunkyo-ku, Japan
  • Boehringer Ingelheim Investigational Site accepting new patients
    Chihuahua, Mexico
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Mexico, Mexico
  • Boehringer Ingelheim Investigational Site accepting new patients
    Toluca, Mexico
  • Boehringer Ingelheim Investigational Site accepting new patients
    Enschede, Netherlands
  • Boehringer Ingelheim Investigational Site accepting new patients
    Heerlen, Netherlands
  • Boehringer Ingelheim Investigational Site accepting new patients
    Rotterdam, Netherlands
  • Boehringer Ingelheim Investigational Site accepting new patients
    Trondheim, Norway
  • Boehringer Ingelheim Investigational Site accepting new patients
    Poznan, Poland
  • Boehringer Ingelheim Investigational Site accepting new patients
    Warsaw, Poland
  • Boehringer Ingelheim Investigational Site accepting new patients
    Lisboa, Portugal
  • Boehringer Ingelheim Investigational Site accepting new patients
    Porto, Portugal
  • Boehringer Ingelheim Investigational Site accepting new patients
    Vila Real, Portugal
  • Boehringer Ingelheim Investigational Site accepting new patients
    Chelyabinsk, Russian Federation
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Kazan, Russian Federation
  • Boehringer Ingelheim Investigational Site accepting new patients
    Krasnoyarsk, Russian Federation
  • Boehringer Ingelheim Investigational Site accepting new patients
    Saint-Petersburg, Russian Federation
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Ufa, Russian Federation
  • Boehringer Ingelheim Investigational Site accepting new patients
    Pretoria, South Africa
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Pretoria, South Africa
  • Boehringer Ingelheim Investigational Site accepting new patients
    Barakaldo (Vizcaya), Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    Barcelona, Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    Donostia (Gipuzkoa), Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    L'Hospitalet de Llobregat, Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    Madrid, Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    Sabadell (Barcelona), Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    Sevilla, Spain
  • Boehringer Ingelheim Investigational Site accepting new patients
    Linköping, Sweden
  • Boehringer Ingelheim Investigational Site accepting new patients
    Lund, Sweden
  • Boehringer Ingelheim Investigational Site in progress, not accepting new patients
    Stockholm, Sweden
  • Boehringer Ingelheim Investigational Site accepting new patients
    Uppsala, Sweden
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Ankara, Turkey
  • Boehringer Ingelheim Investigational Site accepting new patients
    Eskisehir, Turkey
  • Boehringer Ingelheim Investigational Site accepting new patients
    Istanbul, Turkey
  • Boehringer Ingelheim Investigational Site accepting new patients
    Izmir, Turkey
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Exeter, United Kingdom
  • Boehringer Ingelheim Investigational Site not yet accepting patients
    Stockton-on-Tees, United Kingdom

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
Links
http://trials.boehringer-ingelheim.com
ID
NCT01907100
Phase
Phase 3
Lead Scientist
Thierry Jahan
Study Type
Interventional
Last Updated
March 2017
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