CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 107 enrolled
Drug / intervention
Encorafenib +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05004350
NCT05004350Phase 2Completed

A Multicenter, Randomized, Open-label, 2-arm, Phase II Study With a Safety lead-in Phase Evaluating the Combination of Encorafenib and Cetuximab Versus Irinotecan/Cetuximab or Infusional 5-fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab in Chinese Patients With BRAF V600E Mutant Metastatic Colorectal Cancer.

Pierre Fabre Medicament·interventional·Posted Aug 13, 2021·Updated Apr 30, 2026

In Brief

A Phase 2 clinical trial evaluating Encorafenib, Cetuximab, and 1 other intervention for BRAF V600E and Metastatic Colorectal Cancer. Completed, enrolled 107 participants across 34 sites.

Detailed Summary

Encorafenib is currently being developed (with or without binimetinib), in combination with cetuximab, for the treatment of adult patients with B-RAF proto-oncogene, serine/threonine kinase V600E mutant (BRAF V600E) metastatic colorectal cancer (mCRC), who have received prior systemic therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 13, 2021
Enrollment StartSep 14, 2021
Primary CompletionDec 19, 2023
Study CompletionDec 7, 2024
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 4.9 years ago

Interventions

Encorafenibdrug

oral hard capsule

Cetuximabdrug

intravenous infusion

FOLFIRIdrug

Combination of: irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion