Ignite Creation Date:
2024-05-05 @ 9:58 PM
Last Modification Date:
2024-10-26 @ 10:12 AM
Study NCT ID:
NCT01006980
Status:
COMPLETED
Last Update Posted:
2016-09-28
First Post:
2009-10-30
Brief Title:
A Study of Vemurafenib RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma BRIM 3
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
BRIM 3 A Randomized Open-Label Controlled Multicenter Phase III Study in Previously Untreated Patients With Unresectable Stage IIIC or Stage IV Melanoma With V600E BRAF Mutation Receiving Vemurafenib RO5185426 or Dacarbazine
Status:
COMPLETED
Status Verified Date:
2015-12
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 randomized open-label study evaluated the efficacy safety and tolerability of vemurafenib RO5185426 as compared to dacarbazine in previously untreated patients with metastatic melanoma Patients were randomized to receive either vemurafenib 960 mg orally twice daily or dacarbazine 1000 mgm2 intravenously every 3 weeks Study treatment was continued until disease progression or unacceptable toxicity occurred The data and safety monitoring board recommended that patients in the dacarbazine group be allowed to cross over to receive vemurafenib and the protocol was amended accordingly on January 14 2011 as both overall survival and progression-free survival endpoints had met the prespecified criteria for statistical significance in favor of vemurafenib
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 |
|---|---|---|---|
| 2009-012293-12 | None | None | None |