Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patient… (NCT02496585) | Clinical Trial Compass
CompletedPhase 2
Study to Evaluate the Efficacy and Safety of Nintedanib (BIBF 1120) + Prednisone Taper in Patients With Radiation Pneumonitis
United States34 participantsStarted 2015-07-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Histologically/cytologically proven primary thoracic or breast malignancy, lymphoma or lung metastases (which are not required to be biopsy-proven) treated with definitive intent at MSK
* Prior treatment with thoracic radiotherapy completed \>4 weeks and ≤ 9 months prior to enrollment
* Radiographic evidence of radiation pneumonitis on a CT scan of the chest with or without contrast
* Newly diagnosed clinical grade 2 or higher radiation pneumonitis according to CTCAE version 4.0 criteria
* Age≥18 years
* KPS \> 70%
* Reduction of any acute toxicity from radiation treatment to grade 1
* Written informed consent signed prior to entry into the study
Exclusion Criteria:
* Current oral steroid use \> 4 weeks prior to registration
* Ongoing treatment with radiotherapy to thorax, cytotoxic or biological therapies for this malignancy, except the following therapies which are permitted: Pembrolizumab, Nivolumab, Afatinib and all hormonal therapies.
* Mean esophageal radiation dose \>45 Gy
* Diagnosis of diffuse radiation pneumonitis
* Untreated or symptomatic brain metastases or leptomeningeal disease
* Liver metastases
* Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer etc. are eligible)
* Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels
* Active chronic Hepatitis C and/or B infection
* Gastrointestinal disorders that would interfere with drug absor…
What they're measuring
1
Number of Patients Who Are Free From Pulmonary Exacerbations