Ignite Creation Date:
2024-05-06 @ 12:13 AM
Last Modification Date:
2024-10-26 @ 10:46 AM
Study NCT ID:
NCT01524978
Status:
COMPLETED
Last Update Posted:
2017-11-20
First Post:
2012-01-27
Brief Title:
A Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Cancers
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-label Phase II Study of Vemurafenib in Patients With BRAF V600 Mutation-positive Cancers
Status:
COMPLETED
Status Verified Date:
2017-10
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:
This open-label multi-center study will assess the efficacy and safety of vemurafenib in participants with BRAF V600 mutation-positive cancers solid tumors and multiple myeloma except melanoma and papillary thyroid cancer and for whom vemurafenib is deemed the best treatment option in the opinion of the investigator Participants will receive twice daily oral doses of 960 mg vemurafenib until disease progression unacceptable toxicity or withdrawal of consent The safety and efficacy of vemurafenib in combination with cetuximab in a subset of participants with colorectal cancer will also be assessed
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2011-004426-10 | EUDRACT_NUMBER | None | None |