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Ages Eligible for Study:
20 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Histologically or cytologically proven metastatic or locally advanced malignant solid tumors, which are refractory to current standard systemic treatment.
Have measurable lesion.
ECOG performance score no more than 2.
Life expectancy > 12 weeks.
Adequate hematopoietic, hepatic and renal functions.
Hemoglobin > 9.0 g/dl
Absolute neutrophil count > 1,500/mm3
Platelet count 100,000/ mm3
Total bilirubin < 1.5 times the upper limit of normal (ULN)
ALT and AST < 2.5 x ULN
Serum creatinine < 1.0 x ULN
Recovery from prior therapy that given > 4 weeks before enrolment.
No pregnancy and breast-feeding.
Signed informed consent.
Severe cardiovascular disorders.
Pulmonary fibrosis or interstitial pneumonia.
Major anti-cancer treatment within 4 weeks of study entry.
Exposure to the current investigational agent before.
Known or suspected allergy to the current investigational agent.
Unable to swallow oral medications.
Substance abuse, medical, psychological or social conditions interfering with the patient's participation or evaluation of the study results.
Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Symptoms of bowel obstruction, malnutrition, splenomegaly.
Receiving active anti-coagulant therapy.
Patients with concurrent CYP 2A6 and/or CYP 3A4 or 3A5 inducers or inhibitors; a minimal of 2 weeks wash-out period required.