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

Pharmacokinetics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01260025
• Other study ID #: 2009L01132
• Status: Completed
• Phase: Phase 1
• First received: September 8, 2010
• Last updated: February 14, 2012
• Start date: September 2009
• Est. completion date: January 2011

Study information

• Verified date: February 2012
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

1. MTD and DLT of M2ES

2. Pharmacokinetics of M2ES

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Endostatin
• Pharmacokinetics
• Tolerability

Intervention

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.

Locations

Country	Name	City	State
China	Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maxinum tolerated dose of M2ES	To assess the adverse events	one month	Yes
Secondary	Tumor response rate	To assess the tumor response rate of M2ES in patients with solid, malignant tumours	one month	No
Secondary	Pharmacokinetic effect	Pharmacokinetic effect of M2ES in patients with solid, malignant tumours	one month	No
Secondary	DLT of M2ES	To assess the adverse events	one month	Yes