A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
Phase 1
20 Years
N/A
20 Years
N/A
Not Enrolling
Both
Cancer, Solid Tumor, Advanced Solid Tumor
Both
Cancer, Solid Tumor, Advanced Solid Tumor
Trial Information
A Phase I Study of BGT226, Administered Orally in Adult Patients With Advanced Solid Tumor in Japan
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of dose limiting toxicity (DLT) at each dose level
Outcome Time Frame:
22-28 days
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmaceuticals
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
CBGT226A1101
NCT ID:
NCT00742105
Start Date:
November 2008
Completion Date:
Related Keywords:
- Cancer
- Solid Tumor
- Advanced Solid Tumor
- PI3K
- mTOR
- Advanced solid tumor
- Adult
- Neoplasms
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