Phase I Study of Simmitecan Hydrochloride for Injection in Patients With Advanced Solid Tumor：Tolerability and Pharmacokinetics
- Relapsed or refractory to standard therapy or no standard therapy available.
- At least one measurable lesion.
- Age = 18~65 years.
- 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 <
- 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.
- 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
- Significant cardiovascular disease or condition including ≥ class II cardiac function
- 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