Ignite Creation Date:
2024-05-05 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00110994
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2005-05-16
Brief Title:
Treatment for Subjects With Unresectable Stage III or Stage IV Melanoma
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Phase II Randomized Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With Dacarbazine DTIC Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2015-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized double blind placebo controlled multicenter phase II study to compare the anti-tumor activity as measured by progression-free survival PFS and the tolerability of Sorafenib in combination with Dacarbazine DTIC versus DTIC in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy A total of approximately 98 subjects will be randomized to receive DTIC Sorafenib or DTIC Placebo
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