Ignite Creation Date:
2024-05-06 @ 9:13 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02928224
Status:
COMPLETED
Last Update Posted:
2023-12-21
First Post:
2016-08-16
Brief Title:
Study of Encorafenib Cetuximab Plus or Minus Binimetinib vs IrinotecanCetuximab or Infusional 5-Fluorouracil 5-FUFolinic Acid FAIrinotecan FOLFIRICetuximab With a Safety Lead-in of Encorafenib Binimetinib Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Multicenter Randomized Open-label 3-Arm Phase 3 Study of Encorafenib Cetuximab Plus or Minus Binimetinib vs IrinotecanCetuximab or Infusional 5-Fluorouracil 5-FUFolinic Acid FAIrinotecan FOLFIRICetuximab With a Safety Lead-in of Encorafenib Binimetinib Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
Status:
COMPLETED
Status Verified Date:
2023-12
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:
BEACON CRC
Brief Summary:
This is a multicenter randomized open-label 3-arm Phase 3 study to evaluate encorafenib cetuximab plus or minus binimetinib versus Investigators choice of either irinotecancetuximab or FOLFIRIcetuximab as controls in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib binimetinib cetuximab will be assessed prior to the Phase 3 portion of the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| C4221009 | OTHER | Pfizer | None |
| BEACON CRC | OTHER | None | None |
| 2015-005805-35 | EUDRACT_NUMBER | None | None |