NCT01219192

Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

Phase I Study of M2ES in Patients With Advanced Pancreatic Cancer After Gemcitabine Treatment Failure

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Protgen Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.

Detailed description

To evaluate the safety and tolerability and determine the recommended dosing for the treatment in patients with advanced pancreatic cancer after fist-line Gemcitabine treatment failure.We star with the dose M2ES 15mg,then escalate to 30mg 45mg 60mg,to find the recommended dose in clinic practise.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	M2ES	M2ES IV D1,8,15,21 every 28 days a cycle
DRUG	M2ES	M2ES IV D1,8,15,21, every 28days a cyce.
DRUG	M2ES	M2ES 45mg IV D1,8,15,22 28days a cycle
DRUG	M2ES 60mg	M2ES 60mg IV D1,8,15,22 every 28days a cycle

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-10-13
• Last updated: 2010-10-28

Locations

1 site across 1 country: China