Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

Study Overview
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Brief Summary
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This study is dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Detailed Description
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This study is a Phase I dose-escalation open-label study to determine the MTD of M2ES in Subjects With Advanced Solid Tumors the recommended Phase II dose.The recommended dose and regimen of M2ES will be selected to perform the pharmacokinetic study profiles.

Official Title
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Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

Conditions
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Advanced Solid Tumors

Intervention / Treatment
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* Drug: M2ES 7.5mg
* Drug: M2ES 15mg
* Drug: M2ES 30mg
* Drug: M2ES 60mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 60 years of age patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy. life expectancy of at least 3 months. ECOGPS ≤ 1 Adequate hematologic, renal, and hepatic function was required as determined by the following: WBC ≥4×109/L, absolute neutrophil count ≥ 1.5×109/L, platelet count ≥100×109/L, hemoglobin ≥ 9g/dL, total bilirubin ≤1.5 upper limit of normal [ULN],AST ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver metastases; alkaline phosphatase ≤ 2.5 ULN, or ≤ 5 ULN if there was evidence of liver Metastases; creatinine clearance ≥50 mL/min. Exclusion Criteria: Pregnant and latent women, no contraception for women of childbearing age Have taken other treatments Be allergic to endostatin and other ingredient Gastrointestinal Hemorrhage Have Participated any clinical trail during the last 4 week ECG: QTC ≥ 480 ms patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.) Cardiovascular and mental disease HIV-1 infected HBV, HBV infected ,Hepatitis B surface antigen positive Patients on therapeutic doses of heparin or antiplatelet agents.

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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: M2ES 7.5mg<br>M2ES 7.5mg | Drug: M2ES 7.5mg<br>* M2ES 7.5mg<br>* Other names: M2ES 7.5mg IV D1,8,15,22, every 28days a cycle.;|
| Experimental: M2ES 15mg<br>M2ES 15mg | Drug: M2ES 15mg<br>* M2ES 15mg<br>* Other names: M2ES 15mg IV D1,8,15,22, every 28days a cycle.;|
| Experimental: M2ES 30mg<br>M2ES 30mg | Drug: M2ES 30mg<br>* M2ES 30mg<br>* Other names: M2ES 30mg IV D1,8,15,22, every 28days a cycle.;|
| Experimental: M2ES 60mg<br>M2ES 60mg | Drug: M2ES 60mg<br>* M2ES 60mg<br>* Other names: M2ES 60mg IV D1,8,15,22, every 28days a cycle.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The maximum tolerate dosage | The maxium tolerate dosage | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) behavior of M2ES in tumor subject | Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors | 4 week | 
| The incidence rate of adverse event | The incidence rate of adverse event | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Solid Tumors