NCT01218880

Study With M2ES and Gemcitabine for Patients With Advanced Pancreatic Cancer

Phase I Study of M2ES Combined Gemcitabine in Patients With Advanced Pancreatic Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Protgen Ltd · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Phase I trail will be conducted to evaluate the safety of M2ES in combination with gemcitabine in locally advanced or metastatic pancreatic cancer.

Detailed description

Phase I trail will be conducted to determine the MTD and safety of M2ES(administered intravenous infusion on Days 1,8,15,21of a 28-day cycle) in combination with gemcitabine (1000 m/m2). Gemcitabine will be administered as an intravenous infusion on Days 1, 8, and 15 of each 28-day cycle,at the same time determine the safety and efficiency of this combined regime.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	M2ES 7.5mg	M2ES Dosage：7.5mg/m2
DRUG	M2ES 15mg	M2ES Dosage：15mg/m2
DRUG	M2ES 30mg	M2ES Dosage：30mg/m2
DRUG	M2ES 45mg	M2ES Dosage：45mg/m2

Timeline

• Start date: 2010-06-01
• Primary completion: 2011-07-01
• Completion: 2011-12-01
• First posted: 2010-10-11
• Last updated: 2010-10-19

Locations

1 site across 1 country: China