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

February 14, 2012 updated by: Li Zhang, Sun Yat-sen University

Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients received infusion of M2ES for 120 minutes weekly（d1,d8,d15）by calculated pump and underwent evaluation of vital signs including blood pressure, pulse, respiratory rate, and temperature before treatment, at intervals during infusion, and hourly for 6 hours after infusion. After infusion, patients underwent serial pharmacokinetic sampling. All patients were seen weekly during the study therapy and follow-up and underwent evaluation with physical examination including ECOG performance status, vital signs, and laboratory evaluation with complete blood count with manual differential, chemistry evaluation, prothrombin time/partial thromboplastin time, and urinalysis.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PEDylated Recombinant Human Endostatin
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.
Other Names:
  • M2ES

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxinum tolerated dose of M2ES
Time Frame: one month
To assess the adverse events
one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor response rate
Time Frame: one month
To assess the tumor response rate of M2ES in patients with solid, malignant tumours
one month
Pharmacokinetic effect
Time Frame: one month
Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
one month
DLT of M2ES
Time Frame: one month
To assess the adverse events
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

January 1, 2011

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

December 14, 2010

First Posted (ESTIMATE)

December 15, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 16, 2012

Last Update Submitted That Met QC Criteria

February 14, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009L01132

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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