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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2011

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 be selected to perform the pharmacokinetic study profiles.

Interventions

  • Drug: M2ES 7.5mg
    • M2ES 7.5mg
  • Drug: M2ES 15mg
    • M2ES 15mg
  • Drug: M2ES 30mg
    • M2ES 30mg
  • Drug: M2ES 60mg
    • M2ES 60mg

Arms, Groups and Cohorts

  • Experimental: M2ES 7.5mg
    • M2ES 7.5mg
  • Experimental: M2ES 15mg
    • M2ES 15mg
  • Experimental: M2ES 30mg
    • M2ES 30mg
  • Experimental: M2ES 60mg
    • M2ES 60mg

Clinical Trial Outcome Measures

Primary Measures

  • The maximum tolerate dosage
    • Time Frame: 4 weeks
    • The maxium tolerate dosage

Secondary Measures

  • Pharmacokinetic (PK) behavior of M2ES in tumor subject
    • Time Frame: 4 week
    • Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors
  • The incidence rate of adverse event
    • Time Frame: 4 weeks
    • The incidence rate of adverse event

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Protgen Ltd
  • Provider of Information About this Clinical Study
    • Guodong Chang, Protgen Ltd
  • Overall Official(s)
    • Li Zhang, master, Principal Investigator, Sun Yat-sen University
  • Overall Contact(s)
    • Su LI, PhD, 8620-87343571, lisusu@126.com

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