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

Advanced Solid Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01226030
• Other study ID #: PG-2008-2
• Status: Recruiting
• Phase: Phase 1
• First received: October 9, 2010
• Last updated: October 20, 2010
• Start date: September 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2010
• Source: Protgen Ltd
• Contact: Su LI, PhD
• Phone: 8620-87343571
• Email: lisusu[@]126.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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

Locations

Country	Name	City	State
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Protgen Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum tolerate dosage	The maxium tolerate dosage	4 weeks	No
Secondary	Pharmacokinetic (PK) behavior of M2ES in tumor subject	Pharmacokinetic (PK) behavior of different doses of M2ES in Subjects With Advanced Solid Tumors	4 week	Yes
Secondary	The incidence rate of adverse event	The incidence rate of adverse event	4 weeks	Yes