Solid Tumor Clinical Trial
Official title:
Study on the Safety, Tolerability and Pharmacokinetics of Single and Multiple Administration of Injectable PEG-Irinotecan in Patients With Malignant Solid Tumor
The purpose of this clinical trial is to evaluate the safety and tolerability of injectable PEG-Irinotecan in patients with malignant solid tumors
This study is a multicenter, open labeled, positive controlled, single, -combined, with multiple dose escalation trial. The trial consists of 6 drug dose groups, which are 50mg/m2, 75mg/m2, 100mg/m2, 125mg/m2, 150mg/m2 and 180mg/m2 respectively. At each testing dose group, one patient will be treated with HCl-Irinotecan (CPT-11), at dose level of 175mg/m2. The initial dose of 50mg /m2 will be administered once. Starting from the 75mg/m2 dose group, each patient will be given testing drug at least twice. During first and second drug administration, blood samples will be collected for PK characteristics analysis. Patients will be evaluated after every two rounds of drug delivery and preliminary efficacy of testing compound will be determined as PD, SD, CR etc. ;
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