Data from Clinicaltrials.gov - Curated by EPG Health - Last updated 09 July 2018

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...

purpose

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.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Open-label, 3-Arm 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
Study Start Date: August 2016
Estimated Primary Completion Date: July 2019
Estimated Study Completion Date: July 2019

Arm:
- Experimental:
Safety Lead-in, Triplet Arm
- Experimental: Doublet Arm
- Active Comparator: Control Arm

Category Value
Date last updated at source 08-May-18
Study type(s) Interventional
Expected enrolment 645
Study start date 01-Aug-16
Estimated primary completion date 01-Jul-19

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