A Phase I Study of Anlotinib on Tolerance and Pharmacokinetics

Inclusion Criteria:

1. late malignant tumor patients diagnosed with the pathological and/or cytological;

2. lack of the standard treatment or treatment failure;

3. 18-65years, ECOG:0-1,Expected survival period >3 months;

4. stop medicine > 30 days if any other chemotherapy drugs be used.

5. HB≥90g/L,ANC(Absolute Neutrophil Count) ≥1.5×109/L；PLT ≥100×109/L ,BIL/ALT/AST(aspartate aminotransferase )/Cr in normal range,or CCR≥60ml/min,TG≤ 3.0mmol/L，cholesterol≤7.75mmol/L; LVEF≥LLN.

6. Female should be agreed to use contraceptive during the study and after 6 months (such as intrauterine device(IUD), the pill or a condom); The serum or urine pregnancy test negative before take ALTN, and is out of non-lactation period. Male should be agreed to use contraceptive during the study and after the period of 6 months.

7. Volunteer, informed consent form (ICF) signed, compliance.

Exclusion Criteria:

1. Subject was diagnosed with other malignant tumors previously or meanwhile;

2. Participated in other clinical trials in four weeks;

3. Has influence of oral drugs(such as unable to swallow, gastrointestinal tract after resection);

4. Already diagnosed with brain metastases, spinal cord compression, cancerous meningitis, or screening CT or MRI findings of the brain or soft meningeal disease patient;

5. Hypertension

6. Urine protein: ++, and urinary in 24 hours > 1.0g;

7. Coagulant function abnormality: subject with bleeding tendency (such as active peptic ulcer) or are receiving thrombolysis or anticoagulant therapy;

8. Subject with psychiatric drugs abuse history and can't get rid of, or mental disorder;

9. With artery/venous thrombotic before oral ALTN;

10. With history of anticoagulant, vitamin K antagonists(such as warfarin or heparin) or other analogues treatment;

11. With Abnormal thyroid function;

12. With history of psychiatric drugs abuse or a mental disorder;

13. Viral hepatitis B or hepatitis c patients (including hepatitis b, hepatitis c virus carriers);

14. Have immunodeficiency history;

15. According to the researcher's judgment,there are concomitant diseases which will seriously endanger the patients or obstruct the patients to complete the clinical trial.