Trial of BIBF1120 (Nintedanib) in Patients With Recurrent or Metastatic Salivary Gland Cancer of the Head and Neck

Inclusion Criteria: * Histologically proven salivary gland cancer of the head and neck (According to WHO classification, mucoepidermoid cancer, adenoid cystic carcinoma, or adenocarcinoma/salivary duct cancer are eligible) * Recurrent or metastatic salivary gland cancer of the head and neck patients who failed one line of systemic chemotherapy * age ≥ 18 years * At least one measurable tumor lesion according to RECIST 1.1 * ECOG performance status 0-2 * Adequate hematologic function (absolute neutrophil count \> 1,500/m/, platelets \> 100,000/ml, haemoglobin \> 9.0 g/dl), hepatic function (alanine transaminase/aspartate transaminase \< 5 x ULN, total bilirubin \< 1.5 x ULN), renal function (creatinine clearance \> 45 ml/min) * Written informed consent Exclusion Criteria: * Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension, history or myocardial infarction in the 12 months prior to the start of the treatment, or arrhythmia * Hemorrhagic or thromboembolic events in the past 6 months * Major injuries in the 10 days prior to start of the study * Patients with post-obstructive pneumonia or uncontrolled serious infection * Pregnant or nursing women * Uncontrolled symptomatic brain metastasis * Prior history of malignancy within 5 years from study entry except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer, and well treated thyroid cancer