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NCT02928224 · ClinicalTrials.gov registry record · Phase 3
Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 702
- Enrollment target
NCT02928224 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 702 participants.
The verdict
NCT02928224, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 702 participants
- Enrollment target
Study Summary
This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, 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.
Interventions
- DRUG Cetuximab
- DRUG Irinotecan
- DRUG Folinic Acid
- DRUG Binimetinib
- DRUG Encorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 702 participants |
| Start Date | 2016-10-13 |
| Est. Completion | 2022-11-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02928224
The ClinicalTrials.gov registry entry for NCT02928224 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 702 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 1,845 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cetuximab is the first listed.
NCT02928224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02928224 about?
NCT02928224 is a clinical study titled "Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer". This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 pr...
What is the current status of trial NCT02928224?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 702 participants. The study started on 2016-10-13. Estimated completion is 2022-11-10.
What interventions are being tested in trial NCT02928224?
The interventions under investigation include: Cetuximab (DRUG), Irinotecan (DRUG), Folinic Acid (DRUG), Binimetinib (DRUG), Encorafenib (DRUG).
Who is sponsoring clinical trial NCT02928224?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
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