NCT01260025

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tolerability
• Pharmacokinetics
• Endostatin

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-09-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-12-15
• Last updated: 2012-02-16

Locations

1 site across 1 country: China