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

• Status: Terminated
• Trial end date: 2009-12-22
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals

Criteria

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.