A Study Evaluates the Safety, Pharmacokinetics and Efficacy of WX-0593 in Advanced Solid Tumor Patients

Exclusion Criteria

• •1. Clinically significant cardiovascular disease within 3 months prior to first dosing.
• •2. Ongoing cardiac dysrhythmias, or any grade of uncontrolled atrial fibrillation, or prolonged QT interval (QTc \> 480 ms).
• •3. Patients need medications that may prolong QT interval or induce torsades de pointes within 14 days prior to the first dosing or during the study.
• •4. Peripheral neuropathy ≥ Grade 3 according to CTCAE 4.03.
• •5. Patients who received continuous use of steroids for more than 30 days, or who need long-term use of steroid hormones or other immunosuppressive agents.
• •6. History of extensive disseminated/bilateral pulmonary interstitial fibrosis, interstitial fibrosis or interstitial lung disease of Grade 3/4 .
• •7. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of WX-0593.
• •8. Patients who are receiving warfarin sodium (Coumadin) or any other coumadin-derived anticoagulants，and patients with coagulation disturbance and bleeding tendency.
• •9. Patient has received other investigational drug within 1 month.
• •10. Patients with acute or chronic infectious medical conditions, including active hepatitis (Hepatitis A、 Hepatitis B、 Hepatitis C ) or HIV infection.
• •11. Patients who received prior anti-cancer therapy within 2 weeks (t1/2 ≤ 3 days) or within 4 weeks (3 days \< t1/2）. Patients previously treated with crizotinib could start WX-0593 dosing after 1 week from the last dosing.
• •12. Patients who could not discontinue therapy with potent CYP3A4 inhibitors or inducers within 1 week prior first dosing, or patients who need therapy with CYP3A4 inhibitors or inducers during the study.
• •13. Patients received medications known to be metabolized by CYP3A4 and with narrow therapeutic indices, who could not discontinue within 1 week prior to the start of WX-0593 administration. Patients who need therapy with those medications during the study.
• •14. Females who are pregnant or breastfeeding.
• •15. Patients with childbearing potential must agree to use adequate contraception for the duration of treatment and for 6 months after the study.
• •16. Drug abusers and alcoholics.
• •17. History of definite nerves or psychosis diseases including epilepsy or dementia.
• •18. History of other malignancy.
• •19. Concurrent condition that in the investigator's opinion would jeopardize compliance with the protocol or would impart excessive risk associated with study participation that would make it inappropriate for the patient to be enrolled.