NCT00068211

Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma

A Phase II Study of ILX651 Administered Intravenously Daily for Five Consecutive Days Once Every 3 Weeks in Patients With Inoperable Locally Advanced or Metastatic Melanoma.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, non-randomized, open label study of ILX651 in patients with inoperable locally advanced or metastatic melanoma. Approximately 60 patients will be enrolled in this study that is expected to last 18 months. All patients will be treated with ILX651 administered IV daily for 5 consecutive days once every 21 days. The primary objective of this study is to determine the overall response rate for all patients who are treated with ILX651. The secondary objectives are to determine the progression free survival at 18 weeks, duration of response, time to tumor progression, survival, safety/tolerability of ILX651 and to evaluate the pharmacokinetic profile.

Conditions

• Melanoma

Interventions

Type	Name	Description
DRUG	ILX651

Timeline

• Start date: 2003-08-01
• Completion: 2006-01-01
• First posted: 2003-09-11
• Last updated: 2015-03-05

Locations

19 sites across 1 country: United States