Status:
TERMINATED
Phase I Study to Determine the Maximum Tolerate Dose (MTD) of BGT226 in Advanced Solid Tumors in Japan
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Cancer
Solid Tumor
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
Eligibility Criteria
Inclusion
- World Health Organization (WHO) Performance Status of ≤ 2
- Histologically-confirmed, advanced solid tumors
- Progressive, recurrent unresectable disease
- Age ≥ 20
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00742105
Start Date
November 17 2008
End Date
December 22 2009
Last Update
September 25 2018
Active Locations (2)
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1
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 464-8681
2
Novartis Investigative Site
Kobe, Hyōgo, Japan, 650-0017