Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
Status:
Completed
Trial end date:
2006-01-01
Target enrollment:
Participant gender:
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.