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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.
Sun Yat-Sen University
Guangzhou, Guangdong, China
Maxinum tolerated dose of M2ES
To assess the adverse events
Time frame: one month
Tumor response rate
To assess the tumor response rate of M2ES in patients with solid, malignant tumours
Time frame: one month
Pharmacokinetic effect
Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
Time frame: one month
DLT of M2ES
To assess the adverse events
Time frame: one month
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