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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01260025
Recruitment Status : Completed
First Posted : December 15, 2010
Last Update Posted : February 16, 2012
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University

Brief Summary:
  1. MTD and DLT of M2ES
  2. Pharmacokinetics of M2ES

Condition or disease Intervention/treatment Phase
Tolerability Pharmacokinetics Endostatin Drug: PEDylated Recombinant Human Endostatin Phase 1

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  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dose Escalation Study of Tolerability and Pharmacokinetics of PEDylated Recombinant Human Endostatin(M2ES)in the Treatment of Advanced Solid Tumor
Study Start Date : September 2009
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Arm Intervention/treatment
Experimental: PEDylated Recombinant Human Endostatin
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 Name: M2ES

Primary Outcome Measures :
  1. Maxinum tolerated dose of M2ES [ Time Frame: one month ]
    To assess the adverse events

Secondary Outcome Measures :
  1. Tumor response rate [ Time Frame: one month ]
    To assess the tumor response rate of M2ES in patients with solid, malignant tumours

  2. Pharmacokinetic effect [ Time Frame: one month ]
    Pharmacokinetic effect of M2ES in patients with solid, malignant tumours

  3. DLT of M2ES [ Time Frame: one month ]
    To assess the adverse events

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01260025

China, Guangdong
Sun Yat-Sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Principal Investigator: Li Zhang, Professor Sun Yat-sen University

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University Identifier: NCT01260025     History of Changes
Other Study ID Numbers: 2009L01132
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: February 16, 2012
Last Verified: February 2012

Keywords provided by Li Zhang, Sun Yat-sen University:

Additional relevant MeSH terms:
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors