A Study of Anlotinib in Subjects With Advanced Malignancy

Inclusion criteria

• 1) 18~70 years old; Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; Life expectancy ≥ 3 months.

• Histopathologically confirmed advanced malignancy, including gynecological-related tumors, breast cancer, digestive tract tumors, melanoma, and gastrointestinal stromal tumors.

• Has no effective treatment choice, or failure/recurrence after conventional treatment.

• If has received chemotherapy, the treatment has been discontinued for at least 30 days.

• The main organs function are normally. 6) Male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；No pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization.

• Understood and signed an informed consent form.

Exclusion criteria

• 1）Has other malignant tumors. 2) Has participated in other anticancer drug clinical trials within 4 weeks. 3) Has multiple factors affecting oral medication. 4) Has brain metastasis, spinal cord compression, cancerous meningitis. 5) Has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1.

• Has any serious and / or uncontrolled disease. 7) Long-term unhealed wounds or fractures. 8) Has artery/venous thrombosis prior to the first dose within 6 months. 9) Has bleeding tendency or treated with anticoagulants or vitamin K antagonists.

• Has drug abuse history that unable to abstain from or mental disorders. 11)Has history of immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.

• According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.