Clinical Trial: Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Phase II Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumoniti

Brief Summary: The purpose of this study is to find out what effects, good and/or bad, the drug nintedanib in combination with steroids, has on the lungs. Furthermore, such treatments' side effects will be studied together with quality of life. In addition, the investigators would like to determine whether they can find markers in the blood which predict worsening lung injury.

Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: Number of patients who are free from pulmonary exacerbations [ Time Frame: 12 months ]

An acute exacerbation will be defined as (all criteria must be met):

  1. Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days
  2. New or worsening diffuse pulmonary infiltrates on chest CT (with or without contrast) or new high resolution CT parenchymal abnormalities without significant pneumothorax or pleural effusion


Original Primary Outcome: Number of patients who are free from pulmonary exacerbations [ Time Frame: 12 months ]

An acute exacerbation will be defined as (all criteria must be met):

  1. Unexplained worsening or development of cough, dyspnea, hypoxia, or pneumonitis lasting more than 4 days
  2. New or worsening diffuse pulmonary infiltrates on chest CT or new high resolution CT parenchymal abnormalities without significant pneumothorax or pleural effusion


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: July 9, 2015
Date Started: July 2015
Date Completion: July 2019
Last Updated: March 17, 2017
Last Verified: March 2017