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Nintedanib (BIBF 1120) in Mesothelioma

NCT01907100 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 545

Last updated 2019-03-18

Study results available
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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.

Conditions

Interventions

DRUG

Nintedanib

triple kinase inhibitor; 200mg starting dose

DRUG

Pemetrexed

backbone chemo

DRUG

Cisplatin

backbone chemo

DRUG

Cisplatin

backbone chemo

DRUG

Pemetrexed

backbone chemo

DRUG

Placebo

Nintedanib matching placebo

Sponsors & Collaborators

Principal Investigators

  • Boehringer Ingelheim · Boehringer Ingelheim

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-19
Primary Completion
2018-03-16
Completion
2018-08-31

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Canada
  • Chile
  • Croatia
  • Czechia
  • Denmark
  • Egypt
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • South Africa
  • Spain
  • Sweden
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907100 on ClinicalTrials.gov