Advanced Solid Tumor, Cancer, Solid Tumor
Conditions
Keywords
PI3K, mTOR, Advanced solid tumor, Adult
Brief summary
This study will confirm safety and tolerability and determine the MTD of BGT226 in Japanese patients with advanced solid tumor.
Interventions
DRUGBGT226
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limiting toxicity (DLT) at each dose level | 22-28 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of patients in which an altered molecular status is detected for markers related to Pl3K signaling | Baseline, every 3 weeks | — |
| Safety measured by type, frequency and severity of adverse drug reactions | Every 4 weeks | Safety measures by Common Terminology Criteria for Adverse Events (CTCAE) |
| Preliminary Efficacy od BGT226 | Every 8 weeks | Measured by Response Evaluation criteria in Solid Tumors (RECIST) |
| Biomarkers: Percentage of change, pre- versus post-treatment | Every month | — |
Countries
Japan
Outcome results
None listed