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

• Status: Unknown status
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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 selected to perform the pharmacokinetic study profiles.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Protgen Ltd

Criteria

Inclusion Criteria:

1. 18 to 60 years of age

2. patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy.

3. life expectancy of at least 3 months.

4. ECOGPS ≤ 1

5. 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:

1. Pregnant and latent women, no contraception for women of childbearing age

2. Have taken other treatments

3. Be allergic to endostatin and other ingredient

4. Gastrointestinal Hemorrhage

5. Have Participated any clinical trail during the last 4 week

6. ECG: QTC ≥ 480 ms

7. patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)

8. Cardiovascular and mental disease

9. HIV-1 infected

10. HBV, HBV infected ,Hepatitis B surface antigen positive

11. Patients on therapeutic doses of heparin or antiplatelet agents.