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Status:

TERMINATED

Nintedanib (BIBF 1120) in Mesothelioma

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Mesothelioma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

PHASE3

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 pla...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 19 2013

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    August 31 2018

    Estimated Enrollment :

    545 Patients enrolled

    Trial Details

    Trial ID

    NCT01907100

    Start Date

    September 19 2013

    End Date

    August 31 2018

    Last Update

    March 18 2019

    Active Locations (123)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 31 (123 locations)

    1

    University of Alabama at Birmingham

    Birmingham, Alabama, United States, 35249

    2

    University of California San Francisco

    San Francisco, California, United States, 94115

    3

    Rocky Mountain Cancer Centers

    Littleton, Colorado, United States, 80120-4413

    4

    Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, United States, 89052