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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEDylated Recombinant Human Endostatin | Experimental | PEDylated Recombinant Human Endostatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEDylated Recombinant Human Endostatin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Maxinum tolerated dose of M2ES | To assess the adverse events | one month |
| Measure | Description | Time Frame |
|---|---|---|
| Tumor response rate | To assess the tumor response rate of M2ES in patients with solid, malignant tumours | one month |
| Pharmacokinetic effect | Pharmacokinetic effect of M2ES in patients with solid, malignant tumours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Li Zhang, Professor | Sun Yat-sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University | Guangzhou | Guangdong | 510060 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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|
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| one month |
| DLT of M2ES | To assess the adverse events | one month |