NCT00498407

A Phase II Study of CP-4055 as Second Line Therapy in Patients With Advanced Colorectal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Clavis Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Patients with histologically or cytologically confirmed metastatic colorectal cancer (CRC) who have failed a first-line chemotherapeutic regimen containing oxaliplatin and 5-fluorouracil (5-FU) with or without bevacizumab, with or without other Investigational Medicinal Products (IMPs), will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks until complete response or disease worsening/progressing.

Detailed description

This is a multicentre clinical study conducted in the United Kingdom. It is an open label study designed to investigate objective response rate (RR), the time to progression (TTP) and the duration of tumor response in patients with colorectal cancer when treated with CP-4055. The quantitative and qualitative toxicities of the treatment will also be assessed.

Conditions

• Advanced Colorectal Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	CP-4055	CP-4055 5 mg/mL for infusion, dose: 200 mg/m2/day, schedule: d1-5 q4, 30 minutes IV infusion

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2007-07-10
• Last updated: 2009-06-04

Locations

4 sites across 1 country: United Kingdom