Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor

Study Overview
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Brief Summary
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MTD and DLT of M2ES Pharmacokinetics of M2ES

Detailed Description
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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.

Official Title
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Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor

Conditions
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Tolerability, Pharmacokinetics, Endostatin

Intervention / Treatment
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* Drug: PEDylated Recombinant Human Endostatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18 and 65 years;Genders eligible for study: both; Histologic diagnosis of solid malignancies ; Performance status of 0 or 1; Tumor not amenable to standard curative or palliative therapy; life expectancy beyond 3 months; Ability to give signed informed consent Exclusion Criteria: Pregnancy or lactation; Had a history of brain metastasis or a primary brain tumor; An active, potentially severe autoimmune disease; Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance <60ml/min; WBC count < 2.0×109/L，hemoglobin < 90g/L，and platelet count < 100×109/L; Total bilirubin value < 2.0 times the upper limit of normal (ULN), ALT level < 2.0 times ULN, AST < 2.0 times ULN; Positive of anti-HIV antibodies; An active infection; had received chemotherapy or immunotherapy within the prior 4 weeks before study entry Participation in a clinical study during the last 28 days QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEDylated Recombinant Human Endostatin<br>PEDylated Recombinant Human Endostatin | Drug: PEDylated Recombinant Human Endostatin<br>* 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.<br>* Other names: M2ES;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maxinum tolerated dose of M2ES | To assess the adverse events | one month | 

Secondary Outcome Measures

| Outcome Measure | 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 | one month | 
| DLT of M2ES | To assess the adverse events | one month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tolerability, Pharmacokinetics, Endostatin, antiangiogenesis, cancer