Know Cancer

forgot password

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

Phase 1
18 Years
65 Years
Open (Enrolling)
Advanced Solid Tumors

Thank you

Trial Information

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

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.

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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum tolerate dosage

Outcome Description:

The maxium tolerate dosage

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

Li Zhang, master

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University


China: Food and Drug Administration

Study ID:




Start Date:

September 2009

Completion Date:

June 2011

Related Keywords:

  • Advanced Solid Tumors
  • Advanced Solid Tumors
  • Neoplasms