Clinical Trial of Dovitinib in First-line Metastatic or Locally Advanced Non-resectable Adrenocortical Carcinoma

Inclusion Criteria: * Male or female patients aged ≥ 18 years old * A performance status of 0, 1, or 2, according to the Eastern Cooperative Oncology Group (ECOG) scale. * Histologically confirmed adrenocortical carcinoma. * Metastatic or locally advanced non-resectable disease. * At least one radiologically measurable lesion, according to RECIST 1.1. * Adequate liver function as shown by: serum or plasma ALT and AST ≤ 3.0 x ULN (regardless of the presence or absence of metastases)and serum or plasma total bilirubin: ≤ 1.5 x ULN. * Adequate bone marrow function as shown by: blood absolute neutrophil count (ANC) ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L and hemoglobin (Hb) \> 9g/dL. * Adequate renal function as shown by serum creatinine ≤ 1.5 x ULN. * Patients give a written informed consent obtained according to local guidelines. Exclusion Criteria: * Prior chemotherapy other than mitotane (Patients who have previously received mitotane will only be eligible if drig has been withdrawn at least two weeks earlier than dovitinib first dose is administered). * Patients with another primary malignancy within 3 years prior to starting the study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or completely excised basal or squamous cell carcinoma of the skin. * Patients who have received radical radiotherapy ≤4 weeks prior to starting the study treatment or who have not recovered from radiotherapy-related toxicities. Palliative radiotherapy fo…