NCT00563823

Vatalanib in Treating Patients With Metastatic Cutaneous Melanoma That Cannot be Removed by Surgery

A Phase II Study to Evaluate the Efficacy and Safety of PTK787 in Patients With Metastatic Cutaneous Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Cambridge University Hospitals NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Vatalanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well vatalanib works in treating patients with metastatic cutaneous melanoma that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * To determine the response rate in patients with unresectable metastatic cutaneous melanoma treated with vatalanib. Secondary * To determine the time to progression in these patients. * To determine the 6-month and 1-year survival of these patients. * To determine the overall survival of these patients. * To determine the safety and toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive oral vatalanib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed at 8 weeks and then periodically thereafter.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	vatalanib

Timeline

• Start date: 2006-02-01
• Primary completion: 2008-09-01
• Completion: 2010-10-01
• First posted: 2007-11-26
• Last updated: 2013-08-02

Locations

2 sites across 1 country: United Kingdom