Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068211
Status:
COMPLETED
Last Update Posted:
2015-03-05
First Post:
2003-09-09
Brief Title:
Study of ILX651 in Patients With Inoperable Locally Advanced or Metastatic Melanoma
Sponsor:
Genzyme a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
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
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 safetytolerability of ILX651 and to evaluate the pharmacokinetic profile
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None