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COMPLETED
NCT05004350
PHASE2

A Study 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.

Sponsor: Pierre Fabre Medicament

View on ClinicalTrials.gov

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.

Official title: 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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

107

Start Date

2021-09-14

Completion Date

2024-12-07

Last Updated

2026-04-30

Healthy Volunteers

No

Interventions

DRUG

Encorafenib

oral hard capsule

DRUG

Cetuximab

intravenous infusion

DRUG

FOLFIRI

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

Locations (34)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Fujian Medical University - Fujian Provincial Cancer Hospital

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

The First People's Hospital of Foshan

Foshan, Guangdong, China

Cancer Center of Guangzhou Medical University

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital Sun Yat-Sen University

Guangzhou, Guangdong, China

Cancer Hospital Affiliated to Shantou University Medical College

Shantou, Guangdong, China

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

The Affiliated Hospital of Hebei University

Baoding, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital Tongji medical college Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Xiangya Hospital Central South University

Changsha, Hunan, China

The First People's Hospital of Changzhou

Changzhou, Jiangsu, China

First Affiliated Hospital of Gannan Medical University

Ganzhou, Jiangxi, China

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

The First Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital & Institute

Shenyang, Liaoning, China

Shaanxi Provincial People's Hospital

Xi'an, Shaanxi, China

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Huashan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Xinhua Hospital Affilliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai East Hospital, Tongji University

Shanghai, Shanghai Municipality, China

The Second People's Hospital of Neijiang

Neijiang, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital - Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital - Zhejiang University School of Medicine

Hangzhou, Zhejiang, China