From the blog

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:
  • 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
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