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

Korábbi kezelés

• 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
• Other investigational therapy received within 8 weeks prior to screening visit
• Pregnant women or women who are breast feeding or of child bearing potential not using a highly effective method of birth control for at least one month prior to enrollment1

Más betegség

• Diagnosis of diffuse radiation pneumonitis
• Untreated or symptomatic brain metastases or leptomeningeal disease
• Other active malignancies requiring oncologic treatment (Note: non-melanoma skin cancer, superficial bladder cancer etc. are eligible)
• Active chronic Hepatitis C and/or B infection
• Gastrointestinal disorders that would interfere with drug absorption
• Conditions that may affect the patient's ability to participate in this trial, e.g. known or suspected active alcohol or drug abuse
• History of bleeding disorders or thrombotic events, e.g. hemorrhagic or thrombotic events within 12 months, clinically significant or tumor-related hemoptysis, active gastrointestinal bleeding or ulcers or major injuries or surgery
• Known inherited predisposition to thrombosis
• Patient with a history of a thrombotic event within 12 months of starting nintedanib treatment
• Known predisposition to bleeding
• Patients with severe hepatic impairment
• History of a gastrointestinal perforation

Laborértékek

• AST > 1.5 x ULN, ALT>1.5 x ULN and Bilirubin > 1.5 x ULN
• ≥ Grade 2 proteinuria, creatinine >1.5x ULN or GFR <45 ml/min
• Inherited predisposition to bleeding or thrombosis, INR >2, PT and PTT >1.5x ULN
• ANC < 1.5 K/mcL, Platelets < 100 K/mcL, Hemoglobin < 9.0 g/dl
• Concomitant treatment with any of the following drugs: azathioprine, cyclophosphamide, cyclosporine, pirfenidone, full dose anticoagulation (vitamin K antagonists, dabigatran, heparin, etc.), fibrinolysis and high dose anti-platelet therapy (ex. Plavix 150mg)\^2 Myocardial infarction or unstable angina within 6 or 1 month of starting nintedanib treatment, respectively

Egyéb

• Liver metastases
• Radiographic evidence of cavitary or necrotic tumor and local invasion of major blood vessels
• Sexually active males not committing to birth control during the course of the study (except if their partner is not of childbearing potential)

• 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