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


Phase 1
18 Years
65 Years
Not Enrolling
Both
Tolerability, Pharmacokinetics, Endostatin

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maxinum tolerated dose of M2ES

Outcome Description:

To assess the adverse events

Outcome Time Frame:

one month

Safety Issue:

Yes

Principal Investigator

Li Zhang, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sun Yat-sen University

Authority:

China: Food and Drug Administration

Study ID:

2009L01132

NCT ID:

NCT01260025

Start Date:

September 2009

Completion Date:

January 2011

Related Keywords:

  • Tolerability
  • Pharmacokinetics
  • Endostatin
  • Tolerability
  • Pharmacokinetics
  • Endostatin
  • antiangiogenesis
  • cancer

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