Status:
UNKNOWN
Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
Lead Sponsor:
Protgen Ltd
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 select...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2011
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01226030
Start Date
September 1 2009
End Date
June 1 2011
Last Update
October 21 2010
Active Locations (1)
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1
Sun Yat-Sen University Cancer Center
Guangzhou, Guangdong, China