Dovitinib for Gastric Cancer With FGFR2 Amplification: GASDOVI-1

Inclusion Criteria: * Pathologically proven metastatic or unresectable adenocarcinoma of stomach or gastroesophageal junction * Patients with progressive disease (radiological confirmation required) after one or two lines of chemotherapy in palliative setting for advanced gastric cancer. Adjuvant or neoadjuvant chemotherapy is not counted as one line of prior chemotherapy. * FGFR2 amplification (copy number \> 3, identified by real time PCR using TaqMan probe) by prescreening or screening procedure. Prescreening can be performed with Real Time PCR for FGFR2 amplification any time during the prior chemotherapy. At least 18 patients should have 6 or more copy numbers of FGFR2 (see Statistical Methods and Data Analysis). * Presence of at least one measurable disease (for co-primary endpoint of overall response rate in patients with FGFR2 copy number \> 6) or one evaluable disease (for co-primary endpoint of PFS in patients with FGFR2 copy number \> 3) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 * Age of 18 years or older * Expected life expectancy of more than 3 months * ECOG performance status 0\~2 * Resolution of all toxic effects of prior treatments to grade 0 or 1 by NCI-CTCAE version 4.0 * Adequate bone marrow, hepatic, renal, and other organ functions ( Neutrophil \> 1,500/mm3, Platelet \> 75,000/mm3, Hemoglobin \> 8.0 g/dL, Total bilirubin \< 1.5 x upper limit of normal (ULN), AST/ALT \< 2.5 x ULN (or \< 5 x ULM in case of liver metastases), Crea…