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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01260025
First received: September 8, 2010
Last updated: February 14, 2012
Last verified: February 2012

September 8, 2010
February 14, 2012
September 2009
January 2011   (final data collection date for primary outcome measure)
Maxinum tolerated dose of M2ES [ Time Frame: one month ] [ Designated as safety issue: Yes ]
To assess the adverse events
Same as current
Complete list of historical versions of study NCT01260025 on ClinicalTrials.gov Archive Site
  • Tumor response rate [ Time Frame: one month ] [ Designated as safety issue: No ]
    To assess the tumor response rate of M2ES in patients with solid, malignant tumours
  • Pharmacokinetic effect [ Time Frame: one month ] [ Designated as safety issue: No ]
    Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
  • DLT of M2ES [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    To assess the adverse events
Same as current
Not Provided
Not Provided
 
Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor
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

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Tolerability
  • Pharmacokinetics
  • 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
Experimental: PEDylated Recombinant Human Endostatin
PEDylated Recombinant Human Endostatin
Intervention: Drug: PEDylated Recombinant Human Endostatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2011
January 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01260025
2009L01132
Yes
Li Zhang, Sun Yat-sen University
Sun Yat-sen University
Not Provided
Principal Investigator: Li Zhang, Professor Sun Yat-sen University
Sun Yat-sen University
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP