Ignite Creation Date:
2024-05-06 @ 1:06 AM
Last Modification Date:
2024-10-26 @ 10:59 AM
Study NCT ID:
NCT01739764
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2012-11-26
Brief Title:
An Extension Rollover Study of Vemurafenib in Participants With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
An Open-Label Extension Rollover Study of Vemurafenib in Patients With BRAF V600 Mutation-Positive Malignancies Previously Enrolled in an Antecedent Vemurafenib Protocol
Status:
COMPLETED
Status Verified Date:
2020-12
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 open-label multicenter non-randomized study provided continued access to vemurafenib for eligible participants with BRAF V600 mutation-positive malignancy who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocols criteria for disease progression or were treated beyond progression and were still deriving clinical benefit as assessed by investigator and may have therefore potentially benefited from continued treatment with vemurafenib Participants received treatment with oral vemurafenib at 960 milligrams mg twice daily BID 720 mg BID or 480 mg BID depending on the last dose in the antecedent protocol Treatment continued until progression of disease or as long as the participant was deriving clinical benefit as judged by the investigator case-by-case decision with approval of the Medical Monitor death withdrawal of consent unacceptable toxicity loss to follow-up or decision of the Sponsor to terminate the study whichever occurred first
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 |
|---|---|---|---|
| 2012-003144-80 | EUDRACT_NUMBER | None | None |