Ignite Creation Date:
2024-05-06 @ 3:21 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607421
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2020-10-05
Brief Title:
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
AN OPEN-LABEL MULTICENTER RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER
Status:
ACTIVE_NOT_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 purpose of this study is to evaluate two study medicines encorafenib plus cetuximab taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that
has spread to other parts of the body metastatic
has a certain type of abnormal gene called BRAF and
has not received prior treatment
Participants in this study will receive one of the following study treatments
Encorafenib plus cetuximab These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous IV infusion an injection into the vein at the study clinic
Encorafenib plus cetuximab with chemotherapy These participants will receive encorafenib and cetuximab in the way described in the bullet above Additionally they will receive standard chemotherapy by IV infusion and oral treatment at home
Chemotherapy alone These participants will receive chemotherapy the standard treatment for this condition by IV infusion at the study clinics and oral treatment at home
This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone
The study team will monitor how each participant responds to the study treatment for up to about 3 years
has spread to other parts of the body metastatic
has a certain type of abnormal gene called BRAF and
has not received prior treatment
Participants in this study will receive one of the following study treatments
Encorafenib plus cetuximab These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous IV infusion an injection into the vein at the study clinic
Encorafenib plus cetuximab with chemotherapy These participants will receive encorafenib and cetuximab in the way described in the bullet above Additionally they will receive standard chemotherapy by IV infusion and oral treatment at home
Chemotherapy alone These participants will receive chemotherapy the standard treatment for this condition by IV infusion at the study clinics and oral treatment at home
This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone
The study team will monitor how each participant responds to the study treatment for up to about 3 years
Detailed Description:
The purpose of the study is to evaluate whether encorafenib plus cetuximab EC alone or in combination with chemotherapy can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC Since encorafenib has not previously been combined with chemotherapy the tolerability and PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy combination is to be used in the Phase 3 portion of the study
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 |
|---|---|---|---|
| BREAKWATER | OTHER | None | None |
| 2023-509405-77-00 | REGISTRY | Pfizer | None |