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NCT04607421 · ClinicalTrials.gov registry record · Phase 3
A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
A Phase 3 study of Neoplasms, sponsored by Pfizer.
- Active
- Registry status
- Phase 3
- Development phase
- 831
- Enrollment target
- 20
- Study locations
NCT04607421: Active Phase 3 study of Neoplasms, sponsored by Pfizer.
NCT04607421 is a Phase 3 study of Neoplasms that is active but no longer recruiting, run by Pfizer. The registered enrollment target is 831 participants, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04607421, a Phase 3 study of Neoplasms, is active but no longer recruiting, sponsored by Pfizer.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 831 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
DLT: Any AE/lab value during first 28 days (D) of treatment that met at least 1 criteria: AE/lab value unrelated to underlying disease,PD,intercurrent illness,concomitant medications resulting in inability to tolerate atleast 75% of planned dose intensity of study drug,fatigue grade (G)3\>14 consecutive D, interstitial lung disease G\>=2,rash,hand foot skin reaction G3\>14 consecutive D or G4,diarrhea G3 \>=48 hours or G4,nausea/vomiting G3\>=48 hours or G4,mucositis G\>=3,total bilirubin G\>=3,
Conditions Studied
Interventions
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Cetuximab
- DRUG Irinotecan
- DRUG Encorafenib
Study Locations (20)
Illinois
- UChicago Medicine - River East - Chicago
- University of Chicago Medical Center - Chicago
- UChicago Medicine at Ingalls - Flossmoor - Flossmoor
- UChicago Medicine Ingalls Memorial - Harvey
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital - New Lenox
- The University of Chicago Medicine Center for Advanced Care Orland Park - Orland Park
- UChicago Medicine at Ingalls - Tinley Park - Tinley Park
California
- Keck Hospital of USC - Los Angeles
- LAC & USC Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- USC/Norris Comprehensive Cancer Center/Investigational Drug Services - Los Angeles
- USC/Norris Comprehensive Cancer Center - Los Angeles
- Keck Hospital of USC Pasadena - Pasadena
Florida
- Mount Sinai Comprehensive Cancer Center, Aventura - Aventura
- Mount Sinai Comprehensive Cancer Center - Miami Beach
- Mount Sinai Medical Center - Miami Beach
- BRCR Global - Plantation
- BRCR Medical Center Inc. - Plantation
Arizona
- Mayo Clinic Hospital - Phoenix
- Mayo Clinic in Arizona - Scottsdale - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 831 participants |
| Start Date | 2020-12-21 |
| Est. Completion | 2027-12-28 |
| Phase | Phase 3 |
What the registry record for NCT04607421 still lists
NCT04607421 is an interventional study that assigns participants to a tested intervention. The registered 831 participants enrollment target is mid-sized for trials with a published cap, below the 1,616-participant average among 158 other Neoplasms trials with a reported enrollment target (49% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Leucovorin is the first listed.
NCT04607421 names 20 study sites across 4 states, led by Illinois, California, Florida.
Frequently Asked Questions
What is clinical trial NCT04607421 about?
NCT04607421 is a clinical study titled "A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer". 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 "BRA...
What is the current status of trial NCT04607421?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 831 participants. The study started on 2020-12-21. Estimated completion is 2027-12-28.
What conditions does trial NCT04607421 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT04607421?
The interventions under investigation include: Leucovorin (DRUG), Oxaliplatin (DRUG), Cetuximab (DRUG), Irinotecan (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT04607421?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04607421 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04607421's enrollment target sits among peer trials
831 16th of 158 higher than 143 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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