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Brief Title: Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
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 Pneumonitis
Study ID: NCT02496585
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 Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Brigham and Women's Hospital (Data Collection Only), Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center at Basking Ridge, Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth, Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen, Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk, Commack, New York, United States
Memorial Sloan Kettering Westchester, Harrison, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Memorial Sloan Kettering at Mercy Medical Center, Rockville Centre, New York, United States
Memorial Sloan Kettering Nassau, Uniondale, New York, United States
Lehigh Valley Health Network (Data Collection Only), Allentown, Pennsylvania, United States
MD ANDERSON CANCER CENTER (Data Collection Only), Houston, Texas, United States
Myriad Genetic Laboratory (Data or Specimen Analysis Only), Salt Lake City, Utah, United States
Name: Zachary Moore, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: PRINCIPAL_INVESTIGATOR