Spots Global Cancer Trial Database for Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
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Trial Identification
Brief Title: Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer
Official Title: Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer
Study ID: NCT03693170
Study Description
Brief Summary: The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.
Detailed Description: The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration of response, time to response, progression-free survival and overall survival and assess the effect on quality of life. It will also characterize the safety and tolerability of the triple combination as well as describe the pharmacokinetics (PK) of encorafenib, binimetinib, and cetuximab.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Memorial Sloan Kettering Cancer Center, New York, New York, United States
PC dba West Cancer Center, Germantown, Tennessee, United States
Krankenhaus der Barmherzigen Brüder, Wien, , Austria
UZ Gent, Gastro-Enterology, Gent, East Flanders, Belgium
Trial DIO, UZ Gasthuisberg, Leuven, Flemish Brabant, Belgium
Cliniques universitaires Saint-Luc, Brussels, , Belgium
ICM- VAL d 'Aurelle, Montpellier, Cedex 5, France
Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie, Brest, , France
AP-HM CHU Timone, Marseille, , France
Hôpital Cochin Gastroenterology, Paris, , France
Hôpital Europeen Georges Pompidou, Paris, , France
Hôpital Saint Antoine, Paris, , France
HOPITAL HAUT-LEVEQUE, Av de MAGELLAN, Pessac, , France
ICO- Site René Gauducheau, Saint-Herblain, , France
CHU TOULOUSE Rangueil, Toulouse, , France
IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo, Foggia, Italy
Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola, Forlì-Cesena, Italy
Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo, , Italy
Ospedale Policlinic San Martin, Genova, , Italy
Ospedale S.M. Misericordia, Perugia, , Italy
Pierre Fabre Investigative Site, Nagoya, Aichi, Japan
Pierre Fabre Investigative Site, Kashiwa, Chiba, Japan
Pierre Fabre Investigative Site, Fukuoka-shi, Fukuoka, Japan
Pierre Fabre Investigative Site, Osaka-shi, Osaka, Japan
Pierre Fabre Investigative Site, Nagaizumi-cho, Shizuoka, Japan
Pierre Fabre Investigative Site, Koto-ku,, Tokyo, Japan
St Antonius Ziekenhuis, Utrecht, , Netherlands
Hospital Puerta de Hierro, Madrid, Community Of Madrid, Spain
Complejo Hospitalario De Navarra S Oncologia Medica, Pamplona, Navarre, Spain
Hospital Vall d'Hebron, Barcelona, , Spain
Hospital Clínic I Provincial de Barcelona, Barcelona, , Spain
Institut Català d'Oncologia (ICO L'Hospitalet), Barcelona, , Spain
Hospital de la Santa Creu i Santa Pau, Barcelona, , Spain
Hospital General Universitario Gregorio Marañón, Madrid, , Spain
Hospital Universitario HM Sanchinarro, Madrid, , Spain
Hospital Clínico Universitario de, Valencia, , Spain
Hospital Universitario y Politécnico La FE, Valencia, , Spain
Hospital Alvaro Cunqueiro, Vigo, , Spain
Hospital Universitario Miguel Servet, Zaragoza, , Spain
Torbay Hospital, Lowes Bridge, Torquay, Devon, United Kingdom
The Royal Marsden NHS Foundation Trust, Sutton, Surrey, United Kingdom
Beatson West of Scotland Cancer Centre, Glasgow, , United Kingdom
St James Hospital, Leeds, , United Kingdom
GI research team, OHCT, Guy's Hospital, London, , United Kingdom
GI Research Team, The Christie NHS Foundation Trust, Manchester, , United Kingdom
Contact Details
Name: Isabelle KLAUCK, MD
Affiliation: Corporate Medical&Patient/Consumer Division, Pierre Fabre Medicament
Role: STUDY_DIRECTOR
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