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

Novartis

Status and phase: Terminated; Phase 1

Conditions: Solid Tumor; Advanced Solid Tumor; Cancer

Treatments: Drug: BGT226

Study type: Interventional

Funder types: Industry

Identifiers

NCT00742105

CBGT226A1101

Details and patient eligibility

About

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

Enrollment: 18 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

BGT226

Experimental group

Treatment:

Drug: BGT226