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Nintedanib (BIBF 1120) in Mesothelioma

Boehringer Ingelheim logo

Boehringer Ingelheim

Status and phase

Terminated
Phase 3
Phase 2

Conditions

Mesothelioma

Treatments

Drug: Nintedanib
Drug: Placebo
Drug: Cisplatin
Drug: Pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT01907100
1199.93
2012-005201-48 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

545 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

545 participants in 2 patient groups, including a placebo group

Placebo + pemetrexed/cisplatin
Placebo Comparator group
Description:
Placebo controlled arm
Treatment:
Drug: Placebo
Drug: Pemetrexed
Drug: Pemetrexed
Drug: Cisplatin
Drug: Cisplatin
Nintedanib 200mg + pemetrexed/cisplatin
Experimental group
Description:
Experimental arm
Treatment:
Drug: Pemetrexed
Drug: Pemetrexed
Drug: Nintedanib
Drug: Cisplatin
Drug: Cisplatin

Trial documents
2

Trial contacts and locations

123

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Data sourced from clinicaltrials.gov

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