Nintedanib (BIBF 1120) in Mesothelioma

Primary Outcome Measures:

• 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Overall survival measured from the time of randomisation to the time of death of any cause [ Time Frame: up to 4 years ] [ Designated as safety issue: No ]
• Change from baseline in forced vital capacity (pulmonary function) [ Time Frame: up to 3 years ] [ Designated as safety issue: No ]

Eligibility Criteria

Inclusion criteria:

• Histologically confirmed malignant pleural mesothelioma (MPM) (subtype: epithelioid or biphasic)
• 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 VEGFR (Vascular Endothelial Growth Factor Receptor) inhibitor
• Patients with 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