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
  Purpose

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.


Condition Intervention Phase
Advanced Solid Tumors
Drug: M2ES 7.5mg
Drug: M2ES 15mg
Drug: M2ES 30mg
Drug: M2ES 60mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose Escalation and PK Study of M2ES in Subjects With Advanced Solid Tumors

Resource links provided by NLM:


Further study details as provided by Protgen Ltd:

Primary Outcome Measures:
  • The maximum tolerate dosage [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    The maxium tolerate dosage


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 24
Study Start Date: September 2009
Estimated Study Completion Date: June 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: M2ES 7.5mg
M2ES 7.5mg
Drug: M2ES 7.5mg
M2ES 7.5mg
Other Name: M2ES 7.5mg IV D1,8,15,22, every 28days a cycle.
Experimental: M2ES 15mg
M2ES 15mg
Drug: M2ES 15mg
M2ES 15mg
Other Name: M2ES 15mg IV D1,8,15,22, every 28days a cycle.
Experimental: M2ES 30mg
M2ES 30mg
Drug: M2ES 30mg
M2ES 30mg
Other Name: M2ES 30mg IV D1,8,15,22, every 28days a cycle.
Experimental: M2ES 60mg
M2ES 60mg
Drug: M2ES 60mg
M2ES 60mg
Other Name: M2ES 60mg IV D1,8,15,22, every 28days a cycle.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01226030

Contacts
Contact: Su LI, PhD 8620-87343571 lisusu@126.com

Locations
China, Guangdong
Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China
Contact: Su Li, PhD    8620-87343571    lisusu@126.com   
Principal Investigator: LI Zhang, master         
Sponsors and Collaborators
Protgen Ltd
Investigators
Principal Investigator: Li Zhang, master Sun Yat-sen University
  More Information

No publications provided

Responsible Party: Guodong Chang, Protgen Ltd
ClinicalTrials.gov Identifier: NCT01226030     History of Changes
Other Study ID Numbers: PG-2008-2
Study First Received: October 9, 2010
Last Updated: October 20, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Protgen Ltd:
Advanced Solid Tumors

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 16, 2014