Nintedanib (BIBF 1120) in Mesothelioma
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|ClinicalTrials.gov Identifier: NCT01907100|
Recruitment Status : Terminated
First Posted : July 24, 2013
Results First Posted : March 18, 2019
Last Update Posted : March 18, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: Nintedanib Drug: Pemetrexed Drug: Cisplatin Drug: Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||545 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Actual Study Start Date :||September 19, 2013|
|Actual Primary Completion Date :||March 16, 2018|
|Actual Study Completion Date :||August 31, 2018|
Placebo Comparator: Placebo + pemetrexed/cisplatin
Placebo controlled arm
Nintedanib matching placebo
Experimental: Nintedanib 200mg + pemetrexed/cisplatin
triple kinase inhibitor; 200mg starting dose
- Progression-Free Survival (PFS) [ Time Frame: 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) ]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.
- Overall Survival (OS) [ Time Frame: 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) ]
Overall survival was defined as the duration of time from randomization to time of death.
This is the key secondary endpoint of the trial.
- Objective Response According to Modified RECIST- Investigator Assessment [ Time Frame: 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 ]
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.
- Disease Control According to Modified RECIST- Investigator Assessment [ Time Frame: 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 ]
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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907100
|Study Chair:||Boehringer Ingelheim||Boehringer Ingelheim|
Documents provided by Boehringer Ingelheim:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Boehringer Ingelheim|
|Other Study ID Numbers:||
2012-005201-48 ( EudraCT Number )
|First Posted:||July 24, 2013 Key Record Dates|
|Results First Posted:||March 18, 2019|
|Last Update Posted:||March 18, 2019|
|Last Verified:||March 2019|
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
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