A Phase I Study of Anlotinib Hydrochloric Capsule 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.