Ignite Creation Date:
2024-05-06 @ 5:59 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05503797
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-08-15
Brief Title:
A Study to Assess the Efficacy and Safety of FORE8394 in Participants with Cancer Harboring BRAF Alterations
Sponsor:
Fore Biotherapeutics
Organization:
Fore Biotherapeutics
Study Overview
Official Title:
A Phase 2 Master Protocol to Assess the Efficacy and Safety of FORE8394 an Inhibitor of BRAF Class 1 and Class 2 Alterations in Participants with Cancer Harboring BRAF Alterations
Status:
RECRUITING
Status Verified Date:
2024-09
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 objective of this study is to evaluate the efficacy of plixorafenib in participants with locally advanced or metastatic solid tumors or recurrent or progressive primary central nervous system CNS tumors harboring BRAF fusions or in participants with rare solid tumors melanoma thyroid or recurrent primary CNS tumors harboring BRAF V600E mutation This will be conducted as four open-label subprotocols F8394-201A F8394-201B F8394-201C F8394-201D under one master protocol
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-000627-20 | EUDRACT_NUMBER | None | None |