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.

Study Overview

• Status: Unknown
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: M2ES 7.5mg; Drug: M2ES 15mg; Drug: M2ES 30mg; Drug: M2ES 60mg

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Su Li, PhD; Phone Number: 8620-87343571; Email: lisusu@126.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun Yat-Sen University Cancer Center
      • Principal Investigator: LI Zhang, master
      • Contact: Su Li, PhD; Phone Number: 8620-87343571; Email: lisusu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M2ES 7.5mg	Drug: M2ES 7.5mg; M2ES 7.5mg; Other Names: M2ES 7.5mg IV D1,8,15,22, every 28days a cycle.
Experimental: M2ES 15mg	Drug: M2ES 15mg; M2ES 15mg; Other Names: M2ES 15mg IV D1,8,15,22, every 28days a cycle.
Experimental: M2ES 30mg	Drug: M2ES 30mg; M2ES 30mg; Other Names: M2ES 30mg IV D1,8,15,22, every 28days a cycle.
Experimental: M2ES 60mg	Drug: M2ES 60mg; M2ES 60mg; Other Names: M2ES 60mg IV D1,8,15,22, every 28days a cycle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The maximum tolerate dosage	The maxium tolerate dosage	4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Protgen Ltd
• Investigators: Principal Investigator: Li Zhang, Master, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Anticipated): April 1, 2011
• Study Completion (Anticipated): June 1, 2011

Study Registration Dates

• First Submitted: October 9, 2010
• First Submitted That Met QC Criteria: October 20, 2010
• First Posted (Estimate): October 21, 2010

Study Record Updates

• Last Update Posted (Estimate): October 21, 2010
• Last Update Submitted That Met QC Criteria: October 20, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Advanced Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: PG-2008-2