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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Protgen Ltd.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Protgen Ltd
ClinicalTrials.gov Identifier:
NCT01226030
First received: October 9, 2010
Last updated: October 20, 2010
Last verified: October 2010

October 9, 2010
October 20, 2010
September 2009
April 2011   (final data collection date for primary outcome measure)
The maximum tolerate dosage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
The maxium tolerate dosage
Same as current
Complete list of historical versions of study NCT01226030 on ClinicalTrials.gov Archive Site
  • Pharmacokinetic (PK) behavior of M2ES in tumor subject [ Time Frame: 4 week ] [ Designated as safety issue: Yes ]
    Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors
  • The incidence rate of adverse event [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    The incidence rate of adverse event
Same as current
Not Provided
Not Provided
 
Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors
Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Advanced Solid Tumors
  • Drug: M2ES 7.5mg
    M2ES 7.5mg
    Other Name: M2ES 7.5mg IV D1,8,15,22, every 28days a cycle.
  • Drug: M2ES 15mg
    M2ES 15mg
    Other Name: M2ES 15mg IV D1,8,15,22, every 28days a cycle.
  • Drug: M2ES 30mg
    M2ES 30mg
    Other Name: M2ES 30mg IV D1,8,15,22, every 28days a cycle.
  • Drug: M2ES 60mg
    M2ES 60mg
    Other Name: M2ES 60mg IV D1,8,15,22, every 28days a cycle.
  • Experimental: M2ES 7.5mg
    M2ES 7.5mg
    Intervention: Drug: M2ES 7.5mg
  • Experimental: M2ES 15mg
    M2ES 15mg
    Intervention: Drug: M2ES 15mg
  • Experimental: M2ES 30mg
    M2ES 30mg
    Intervention: Drug: M2ES 30mg
  • Experimental: M2ES 60mg
    M2ES 60mg
    Intervention: Drug: M2ES 60mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
June 2011
April 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Su LI, PhD 8620-87343571 lisusu@126.com
China
 
NCT01226030
PG-2008-2
Yes
Guodong Chang, Protgen Ltd
Protgen Ltd
Not Provided
Principal Investigator: Li Zhang, master Sun Yat-sen University
Protgen Ltd
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP