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

Condition Intervention Phase
Tolerability
Pharmacokinetics
Endostatin
Drug: PEDylated Recombinant Human Endostatin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Maxinum tolerated dose of M2ES [ Time Frame: one month ] [ Designated as safety issue: Yes ]
    To assess the adverse events


Secondary Outcome Measures:
  • 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


Enrollment: 20
Study Start Date: September 2009
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01260025

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

No publications provided

Responsible Party: Li Zhang, Profressor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01260025     History of Changes
Other Study ID Numbers: 2009L01132
Study First Received: September 8, 2010
Last Updated: February 14, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Tolerability
Pharmacokinetics
Endostatin
antiangiogenesis
cancer

Additional relevant MeSH terms:
Endostatins
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014