An Open-Label Phase I Dose-Escalation Study of Sorafenib Plus S-1 in Advanced Solid Tumors
- Histologically or cytologically proven metastatic or locally advanced malignant solid
tumors, which are refractory to current standard systemic treatment.
- Have measurable lesion.
- 20-75 y/o.
- ECOG performance score no more than 2.
- Life expectancy > 12 weeks.
- Adequate hematopoietic, hepatic and renal functions.
1. Hemoglobin > 9.0 g/dl
2. Absolute neutrophil count > 1,500/mm3
3. Platelet count 100,000/ mm3
4. Total bilirubin < 1.5 times the upper limit of normal (ULN)
5. ALT and AST < 2.5 x ULN
6. 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.
- HIV infection.
- Active infection.
- 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.