Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor

NCT01260025 | Completed Phase 1 DMC

• 1 other identifier: 2009L01132
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.MTD and DLT of M2ES
2. 2.Pharmacokinetics of M2ES

Conditions

Tolerability; Pharmacokinetics; Endostatin

Keywords

Tolerability; Pharmacokinetics; Endostatin; antiangiogenesis; cancer

Outcome Measures

Primary Outcomes (1)

• Maxinum tolerated dose of M2ES

  To assess the adverse events

  one month

Secondary Outcomes (3)

• Tumor response rate

  one month

• Pharmacokinetic effect

  one month

• DLT of M2ES

  one month

Study Arms (1)

PEDylated Recombinant Human Endostatin

EXPERIMENTAL

PEDylated Recombinant Human Endostatin

Drug: PEDylated Recombinant Human Endostatin

Interventions

PEDylated Recombinant Human Endostatin DRUG

The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.

Also known as: M2ES

PEDylated Recombinant Human Endostatin

Eligibility Criteria

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

You may qualify if:

• Age between 18 and 65 years;Genders eligible for study: both;
• Histologic diagnosis of solid malignancies ;
• Performance status of 0 or 1;
• Tumor not amenable to standard curative or palliative therapy;
• life expectancy beyond 3 months;
• Ability to give signed informed consent

You may not qualify if:

• Pregnancy or lactation;
• Had a history of brain metastasis or a primary brain tumor;
• An active, potentially severe autoimmune disease;
• Serum creatinine ≥1.5mg/dl or a calculated creatinine clearance \<60ml/min; WBC count \< 2.0×109/L，hemoglobin \< 90g/L，and platelet count \< 100×109/L; Total bilirubin value \< 2.0 times the upper limit of normal (ULN), ALT level \< 2.0 times ULN, AST \< 2.0 times ULN;
• Positive of anti-HIV antibodies;
• An active infection;
• had received chemotherapy or immunotherapy within the prior 4 weeks before study entry
• Participation in a clinical study during the last 28 days
• QTc with Bazett's correction unmeasurable or ≥ 480 msec on screening ECG

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Li Zhang, Professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profressor

Study Record Dates

• First Submitted: September 8, 2010
• First Posted: December 15, 2010
• Study Start: September 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: February 16, 2012

Record last verified: 2012-02

Locations

CN (1)