A Phase I Dose Escalating Study to Evaluate TKI258 Administered Orally on a 5 Days on/2days Off Schedule in Japanese Patients With Advanced Solid Tumors
Inclusion Criteria:
- Written informed consent must be obtained prior to any screening procedures
- Advanced solid tumors
- Agreement to remaining hospitalized
- ECOG performance status of 0 or 1
- Life expectancy of at least 3 months
- Pregnant women. Male and female patients of reproductive potential must agree to
employ an effective method of birth control
- Demonstrate the specific hematological /blood chemistry laboratory values
Exclusion Criteria:
- Receipt of any investigational compound within 28 days prior to the first dose of
study drug or failure to have recovered from the side effects of such prior therapy
- Receipt of other antineoplastic therapy, including chemo-, hormonal, immuno-, and
radiation therapy, within 28 days (with some exceptions)
- Patients with CNS and/or leptomeningeal disease metastases
- Presence or history of thromboembolic or cerebrovascular events
- Impaired cardiac function or clinically significant cardiac disease
- Malabsorption syndrome or uncontrolled gastrointestinal toxicities
- Patients known to be HIV- or HBV- or HCV- positive
- Patients with acute or chronic uncontrolled infection
- Patients who have undergone surgery with general anesthesia for any cause within 28
days prior to the first dose of study drug
- Patients who have been receiving anticoagulant therapy
- Receipt of any hematopoietic colony stimulating factor or blood transfusion within 14
days prior to the first dose of study drug
- Patients who have been administering concomitant medication which may prolong the QTc
interval
- Patients with interstitial pneumonia or pulmonary fibrosis proven on a chest CT scan
- Patients with a large volume of ascitic and/or pleural fluid which requires drainage
- Patients with any bone fractures
- Deemed otherwise unsuitable by the investigator
Other protocol-defined inclusion/exclusion criteria may apply