advanced solid tumors
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Eligible patients were aged 18–75 years, with a cytologically or histologically confirmed advanced solid tumors refractory to standard therapies or for which a standard effective therapy did not exist; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2; Karnofsky score >=60%; a life expectancy>=3 months; practicing adequate contraception; an adequate haematological function [white blood cell (WBC) count >=4.0*10^9/l; absolute neutrophil count (ANC) >=2.0*10^9/l; platelet count >=100*10^9/l; haemoglobin >=100 g/l]; adequate hepatic and renal function [alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) <=2.5 the upper limit of normal (ULN) or 5*ULN for hepatic cancer/metastatic hepatic cancer; total bilirubin (TBIL) <=1.5*ULN; serum creatinine <=1.5*ULN; creatinine clearance rate<=1.5*ULN; normal UREA]; normal pulmonary function.
Exclusion criteria
Exclusion criteria: 1. be going to be receved other therapy; 2. pregnancy; 3. and so on.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety, the recommended dose (RD) for phase II trial, pharmacokinetics; | — |
Countries
China