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

TerminadoFase 3ClinicalTrials.gov

ID: NCT01907100Tipo: INTERVENTIONALInicio: 19 de sept de 2013Fin estimado: 31 de ago de 2018

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

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

Intervenciones

drug

Nintedanib

triple kinase inhibitor; 200mg starting dose

drug

Pemetrexed

backbone chemo

drug

Cisplatin

backbone chemo

drug

Cisplatin

backbone chemo

drug

Pemetrexed

backbone chemo

drug

Placebo

Nintedanib matching placebo

Ubicaciones

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

Patrocinadores

PrincipalBoehringer Ingelheim

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