Study of Simmitecan Hydrochloride in the Treatment of Advanced Solid Tumor

Inclusion criteria

• Relapsed or refractory to standard therapy or no standard therapy available.
• At least one measurable lesion.
• Age = 18~65 years.
• ECOG=0-1.
• Life expectancy ≥ 12 weeks.
• More than 4 weeks after operation, chemotherapy, radiotherapy, cytotoxic agents or tyrosine kinase inhibitors.
• Adequate organ function:

Haemoglobin ≥ 100 g/L, Absolute neutrophil count [ANC] ≥ 2×109/L,Platelets ≥ 100 × 109/L), Serum bilirubin ≤ 1.0×ULN, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 1.5×ULN (If liver metastases, serum transaminase ≤ 2.5×ULN), Creatinine clearance ≥ 50 mL/min , LVEF ≤ 50%, QT interval (corrected by Fridericia): male < 450 ms, female < 470 ms

• Female: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article. Child bearing potential, a negative urine or serum pregnancy test result before initiating Famitinib. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 6 months after the last dose of test article.
• Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

Exclusion criteria

• Less than 4 weeks from the last clinical trial.
• Known Spinal Cord compression or diseases of brain or pia mater by CT /MRI screening.
• Patients had ever severe diarrhea with prior therapy of camptothecin drugs.
• Concurrent severe or uncontrolled medical disease (serious infection, serious diabetes)
• Significant cardiovascular disease or condition including ≥ class II cardiac function (NYHA)
• Acute and chronic viral hepatitis. (If HBsAg +, HBV-DNA quantification ≤ LLN.)
• Pregnant, lactation period or men/women ready to birth.
• Psychiatric disorder or altered mental status.
• Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study