Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan

A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan

This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.

Inclusion Criteria:

• World Health Organization (WHO) Performance Status of ≤ 2
• Histologically-confirmed, advanced solid tumors
• Progressive, recurrent unresectable disease
• Age ≥ 20

Exclusion Criteria:

• Hematopoietic:
• No diabetes mellitus or history of gestational diabetes mellitus
• No acute or chronic renal disease
• No acute or chronic liver disease
• No acute or chronic pancreatitis
• No impaired cardiac function or clinically significant cardiac diseases such as ventricular arrhythmia, congestive heart failure, uncontrolled hypertension
• No acute myocardial infarction or unstable angina pectoris within the past 3 months
• Not pregnant or nursing and fertile patients must use barrier contraceptives

Other protocol-defined inclusion/exclusion criteria may apply.