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

NCT01226030 | Unknown Phase 1 DMC

• 1 other identifier: PG-2008-2
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumors

Keywords

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• The maximum tolerate dosage

  The maxium tolerate dosage

  4 weeks

Secondary Outcomes (2)

• Pharmacokinetic (PK) behavior of M2ES in tumor subject

  4 week

• The incidence rate of adverse event

  4 weeks

Study Arms (4)

M2ES 7.5mg

EXPERIMENTAL

M2ES 7.5mg

Drug: M2ES 7.5mg

M2ES 15mg

EXPERIMENTAL

M2ES 15mg

Drug: M2ES 15mg

M2ES 30mg

EXPERIMENTAL

M2ES 30mg

Drug: M2ES 30mg

M2ES 60mg

EXPERIMENTAL

M2ES 60mg

Drug: M2ES 60mg

Interventions

M2ES 7.5mg DRUG

M2ES 7.5mg

Also known as: M2ES 7.5mg IV D1,8,15,22, every 28days a cycle.

M2ES 7.5mg

M2ES 15mg DRUG

M2ES 15mg

Also known as: M2ES 15mg IV D1,8,15,22, every 28days a cycle.

M2ES 15mg

M2ES 30mg DRUG

M2ES 30mg

Also known as: M2ES 30mg IV D1,8,15,22, every 28days a cycle.

M2ES 30mg

M2ES 60mg DRUG

M2ES 60mg

Also known as: M2ES 60mg IV D1,8,15,22, every 28days a cycle.

M2ES 60mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 60 years of age
• patients had histologically or cytologically confirmed solid tumors that was refractory to standard therapy.
• life expectancy of at least 3 months.
• ECOGPS ≤ 1
• 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.

You may not qualify if:

• Pregnant and latent women, no contraception for women of childbearing age
• Have taken other treatments
• Be allergic to endostatin and other ingredient
• Gastrointestinal Hemorrhage
• Have Participated any clinical trail during the last 4 week
• ECG: QTC ≥ 480 ms
• patients had clinically apparent CNS disease ( primary brain tumors, tumor related apoplexy, CNS metastases, carcinomatous meningitis.)
• Cardiovascular and mental disease
• HIV-1 infected
• HBV, HBV infected ,Hepatitis B surface antigen positive
• Patients on therapeutic doses of heparin or antiplatelet agents.

Sponsors & Collaborators

• Protgen Ltd: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Study Officials

• Li Zhang, master

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Su LI, PhD

CONTACT

8620-87343571; lisusu@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2010
• First Posted: October 21, 2010
• Study Start: September 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 21, 2010

Record last verified: 2010-10

Locations

CN (1)