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

NCT ID: NCT01226030

Last Updated: 2010-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Advanced Solid Tumors

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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M2ES 7.5mg

M2ES 7.5mg

Group Type EXPERIMENTAL

M2ES 7.5mg

Intervention Type DRUG

M2ES 7.5mg

M2ES 15mg

M2ES 15mg

Group Type EXPERIMENTAL

M2ES 15mg

Intervention Type DRUG

M2ES 15mg

M2ES 30mg

M2ES 30mg

Group Type EXPERIMENTAL

M2ES 30mg

Intervention Type DRUG

M2ES 30mg

M2ES 60mg

M2ES 60mg

Group Type EXPERIMENTAL

M2ES 60mg

Intervention Type DRUG

M2ES 60mg

Interventions

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M2ES 7.5mg

M2ES 7.5mg

Intervention Type DRUG

M2ES 15mg

M2ES 15mg

Intervention Type DRUG

M2ES 30mg

M2ES 30mg

Intervention Type DRUG

M2ES 60mg

M2ES 60mg

Intervention Type DRUG

Other Intervention Names

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M2ES 7.5mg IV D1,8,15,22, every 28days a cycle. M2ES 15mg IV D1,8,15,22, every 28days a cycle. M2ES 30mg IV D1,8,15,22, every 28days a cycle. M2ES 60mg IV D1,8,15,22, every 28days a cycle.

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Protgen Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Protgen Ltd

Principal Investigators

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Li Zhang, master

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

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Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Su LI, PhD

Role: CONTACT

[email protected]
8620-87343571

Facility Contacts

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Su Li, PhD

Role: primary

[email protected]
8620-87343571

Other Identifiers

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PG-2008-2

Identifier Type: -

Identifier Source: org_study_id