Sorafenib Gastric Cancer Asian Phase I Study

Phase I Study to Investigate Safety, Pharmacokinetics and Preliminary Efficacy Profile of Sorafenib (BAY 43-9006) in Combination With S-1 Plus CDDP in Asian Patients With Unresectable / Recurrent Gastric Cancer

This study is to investigate safety, pharmacokinetics and preliminary efficacy profile of sorafenib in combination with S-1 plus cisplatin in Asian patients with unresectable / recurrent gastric cancer.

Inclusion Criteria:

• Histological or cytological confirmation of the primary unresectable or recurrent gastric cancer (both with and without measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) are allowed). Peritoneal dissemination without ascites is allowed.
• No prior systemic anticancer therapy including chemotherapy, immunotherapy, targeted agents or experimental therapies for advanced disease
• Prior adjuvant therapy/neo adjuvant therapy is allowed if recurrence occurred 6 months after completion of these therapies
• Age >/= 18 years and < 75 years

Exclusion Criteria:

• Known brain metastasis, spinal cord compression or meningeal carcinomatosis.
• Clinically relevant ascites
• Concurrent cancer that is distinct in primary site or histology from gastric cancer
• Any condition that impairs patient's ability to swallow whole pills