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Nintedanib (BIBF 1120) in Mesothelioma

Brief Summary

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.

Tracking Information
First Received DateJuly 22, 2013
Last Changed DateSeptember 10, 2018
Start DateSeptember 19, 2013
Actual Primary Completion DateMarch 16, 2018
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]

Secondary Outcome Measures

Overall survival measured from the time of randomisation to the time of death of any cause [Time Frame: up to 3 years]

Objective response according to modified RECIST analysed by objective response rate [Time Frame: up to 3 years]

Disease control according to modified RECIST analysed by disease control rate [Time Frame: up to 3 years]

Descriptive Information
PhasePhase 3
Study TypeInterventional
  • Mesothelioma
  • Drug: Nintedanib
  • Drug: Pemetrexed
  • Drug: Cisplatin
  • Drug: Cisplatin
  • Drug: Pemetrexed
  • Drug: Placebo
Study Arms / Comparison Groups2 / 0
Recruitment Information
Recruitment StatusCompleted
Actual Enrollment545
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria

Inclusion criteria:

- 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

Exclusion 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

Administrative Information
Responsible PartySponsor
SponsorBoehringer Ingelheim
Verification DateSeptember 2018
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