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

NCT01260025 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2012-02-16

No results posted yet for this study

Summary

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

Conditions

  • Tolerability
  • Pharmacokinetics
  • Endostatin

Interventions

DRUG

PEDylated Recombinant Human Endostatin

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Li Zhang, Professor · Sun Yat-sen University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01260025 on ClinicalTrials.gov