NCT06640166View on ClinicalTrials.gov

Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab.

PHASE2RecruitingINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

June 3, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

June 30, 2026

Conditions
Colorectal CarcinomaColorectal NeoplasmsColorectal TumorColorectal AdenocarcinomaColorectal Cancer (CRC)Colorectal CancerColon CancerColon AdenocarcinomaColon CarcinomaColon Neoplasm
Interventions
DRUG

encorafenib + cetuximab + FOLFIRI

"encorafenib plus cetuximab beyond progression in combination with irinotecan-based doublet chemoterapy (FOLFIRI) as follows:~* encorafenib 300 mg (75 mgx4 hard capsules) orally once daily;~* cetuximab 500 mg/sqm iv every 14 days;~* FOLFIRI iv every 14 days (Irinotecan 180 mg/sqm, Folinic Acid 400 mg/sqm, 5Fluorouracil 400 mg/sqm iv bolus and 2400 mg/sqm iv continuous infusion over 46-48 hours)."

Trial Locations (3)

20133

NOT_YET_RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

73039

RECRUITING

Ospedale Cardinale G. Panico, Tricase

00136

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Roma

All Listed Sponsors
collaborator

Pierre Fabre Pharma GmbH

INDUSTRY

lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

NCT06640166 - Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Colorectal Cancer Progressing on Encorafenib + Cetuximab. | Biotech Hunter | Biotech Hunter