Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01378975
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2011-06-21
Brief Title:
A Study of Vemurafenib in Metastatic Melanoma Participants With Brain Metastases
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Single-arm Phase II Multicenter Study to Evaluate the Efficacy of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases
Status:
COMPLETED
Status Verified Date:
2016-04
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 open-label single-arm multicenter study will evaluate the efficacy and safety in participants with metastatic melanoma who developed brain metastases Participants may or may not have received prior systemic treatment for metastatic melanoma except treatment with v-raf murine sarcoma viral oncogene homolog B BRAF or mitogen-activated protein kinase MEK inhibitors Participants will receive oral doses of 960 mg vemurafenib twice daily until disease progression unacceptable toxicity or consent withdrawal
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