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

Phase 1

Completed

• Conditions: Pharmacokinetics; Endostatin; Tolerability
• Interventions: Drug: PEDylated Recombinant Human Endostatin

• Registration Number: NCT01260025
• Lead Sponsor: Sun Yat-sen University

Brief Summary

1. MTD and DLT of M2ES

2. Pharmacokinetics of 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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-09-08
• Study First Submitted QC: 2010-12-14
• Study First Posted: 2010-12-15
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PEDylated Recombinant Human Endostatin	PEDylated Recombinant Human Endostatin	PEDylated Recombinant Human Endostatin

Primary Outcome Measures

Name	Time	Method
Maxinum tolerated dose of M2ES	one month	To assess the adverse events

Secondary Outcome Measures

Name	Time	Method
DLT of M2ES	one month	To assess the adverse events
Pharmacokinetic effect	one month	Pharmacokinetic effect of M2ES in patients with solid, malignant tumours
Tumor response rate	one month	To assess the tumor response rate of M2ES in patients with solid, malignant tumours

Trial Locations

Locations (1)

Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China