Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maxinum tolerated dose of M2ES
To assess the adverse events
one month
Yes
Li Zhang, Professor
Principal Investigator
Sun Yat-sen University
China: Food and Drug Administration
2009L01132
NCT01260025
September 2009
January 2011
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