Nintedanib (BIBF 1120) in Mesothelioma
Published: August 19, 2013
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:
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- 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:
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- 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