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

Phase 1

• Conditions: Advanced Solid Tumors
• Interventions: Drug: M2ES 7.5mg; Drug: M2ES 15mg; Drug: M2ES 30mg; Drug: M2ES 60mg

• Registration Number: NCT01226030
• Lead Sponsor: Protgen Ltd

Brief 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.

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-10
• Study First Submitted: 2010-10-09
• Study First Submitted QC: 2010-10-20
• Last Update Submitted: 2010-10-20
• Study First Posted: 2010-10-21
• Last Update Posted: 2010-10-21
• Primary Completion: 2011-04
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M2ES 7.5mg	M2ES 7.5mg	M2ES 7.5mg
M2ES 15mg	M2ES 15mg	M2ES 15mg
M2ES 30mg	M2ES 30mg	M2ES 30mg
M2ES 60mg	M2ES 60mg	M2ES 60mg

Primary Outcome Measures

Name	Time	Method
The maximum tolerate dosage	4 weeks	The maxium tolerate dosage

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sun Yat-Sen University Cancer Center; 🇨🇳 Guangzhou, Guangdong, China