Pharmacokinetics Clinical Trial
Official title:
Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
1. MTD and DLT of M2ES
2. Pharmacokinetics of M2ES
Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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