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Nintedanib (BIBF 1120) in Mesothelioma

This study is currently recruiting participants.
Verified November 2017 by Boehringer Ingelheim
Sponsor:
ClinicalTrials.gov Identifier:
NCT01907100
First Posted: July 24, 2013
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
July 22, 2013
July 24, 2013
November 17, 2017
September 19, 2013
October 30, 2019   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01907100 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Overall survival measured from the time of randomisation to the time of death of any cause [ Time Frame: up to 4 years ]
  • Change from baseline in forced vital capacity (pulmonary function) [ Time Frame: up to 3 years ]
Not Provided
Not Provided
 
Nintedanib (BIBF 1120) in Mesothelioma
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
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Mesothelioma
  • Drug: Nintedanib
    triple kinase inhibitor; 200mg starting dose
  • Drug: Pemetrexed
    backbone chemo
  • Drug: Cisplatin
    backbone chemo
  • Drug: Placebo
    Nitedanib matching placebo
  • Placebo Comparator: Placebo + pemetrexed/cisplatin
    Placebo controlled arm
    Interventions:
    • Drug: Pemetrexed
    • Drug: Cisplatin
    • Drug: Placebo
  • Experimental: Nintedanib 200mg + pemetrexed/cisplastin
    Experimental arm
    Interventions:
    • Drug: Nintedanib
    • Drug: Cisplatin
    • Drug: Pemetrexed
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
537
October 30, 2019
October 30, 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Boehringer Ingelheim Call Center 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com
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,   United States
Czech Republic
 
NCT01907100
1199.93
2012-005201-48 ( EudraCT Number )
Not Provided
Not Provided
Not Provided
Boehringer Ingelheim
Boehringer Ingelheim
Not Provided
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
Boehringer Ingelheim
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP