Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111007
Status:
COMPLETED
Last Update Posted:
2014-10-31
First Post:
2005-05-16
Brief Title:
A Treatment Combination for Patients With Unresectable Stage III or Stage IV Melanoma
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Phase III Randomized Placebo Controlled Study of Sorafenib in Repeated Cycles of 21 Days in Combination With PaclitaxelCarboplatin Chemotherapy in Subjects With Unresectable Stage III or Stage IV Melanoma
Status:
COMPLETED
Status Verified Date:
2014-10
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:
The objectives of this study are to compare the anti-tumor activity as measured by Progression Free Survival PFS and tolerability of Sorafenib in combination with Paclitaxel and Carboplatin versus Paclitaxel and Carboplatin in combination with placebo in subjects with unresectable Stage III or Stage IV melanoma who progressed after receiving only one prior therapy containing Dacarbazine DTIC or Temozolomide TMZ
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2005-000941-12 | EUDRACT_NUMBER | None | None |